CDE Detailed Report
Disease: system
Subdomain Name: Surgeries and Other Procedures
CRF: files
Displaying 51 - 100 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: files
Displaying 51 - 100 of 114
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02305 | Adverse event severity scale grade | AdvrsEvntSeverSclGrade | The grading scale of the severity or intensity of the adverse event | The grading scale of the severity or intensity of the adverse event | Complications Severity | Grade 1;Grade 3;Grade 5;Grade 2;Grade 4 | Asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, limiting self care Activities of Daily Living;Death;Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living;Life-threatening consequences, urgent intervention indicated | Alphanumeric |
Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v5.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites. |
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (https://evs.nci.nih.gov/ftp1/CTCAE/About.html) | Adult | Supplemental | 5.00 | 2022-07-29 12:16:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2201188 | |||||||
| C59153 | Lead extender remove count | LeadExtndrRemoveCt | Count of lead extenders removed | Count of lead extenders removed | Lead extender (specify # of extenders removed) | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:20:05.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C18757 | Surgery lead secure method type other text | SurgLeadSecurMethdTypOTH | The free-text field related to 'Surgery lead secure method type', specifying other text. Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still | Field related to 'Surgery lead secure method type', specifying other text. Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position | Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:46:28.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59131 | Stimulation brain parameter positive contact text | StimBrainParamPostveContactTxt | Text related to positive contact brain stimulation parameters | Text related to positive contact brain stimulation parameters | Positive contacts(s) | Alphanumeric |
Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:32:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08035 | Stereotactic surgery frame type | StereotactSurgFrmTyp | Scaffold or support used for stereotactic surgery | Scaffold or support used for stereotactic surgery | Mechanical guidance for lead insertion | Other, specify;CRW headframe;Leksell headframe;Single use mini-frame | Other, specify;CRW headframe;Leksell headframe;Single use mini-frame ("frameless") | Alphanumeric |
CRW (manufactured by Radionics) and Leksell (manufactured by Elekta) are the two most common frame types. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:07:57.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59586 | Stereotactic surgery mini-frame type other text | StereotactSurgMiniFrmTypOTH | The free-text field related to 'Stereotactic surgery mini-frame type', specifying other text. Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surgery | The free-text field related to 'Stereotactic surgery mini-frame type', specifying other text. Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surgery | Other, specify | Alphanumeric |
Only answer if 'mini-frame' is answered for 'Frame Type' |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 16:54:57.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59090 | Deep brain stimulation indication type other text | DBSIndicationTypOTH | The free-text field related to 'Deep brain stimulation indication type', specifying other text. Type of indications for deep brain stimulation (DBS) | The free-text field related to 'Deep brain stimulation indication type', specifying other text. Type of indications for deep brain stimulation (DBS) | Other indication, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:27:45.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59143 | Unified Parkinsons Disease Rating Scale part three on DBS on medication score | UPDRSPtThreeOnDBSOnMedScore | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications | UPDRS part 3 score, on DBS, on medication | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:57:03.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08051 | Stimulation parameter brain hemisphere type | StimParamBrainHemisphTyp | Side of the brain targeted for stimulation | Side of the brain targeted for stimulation | Left Brain Right Brain | Right;Left | Right Brain;Left Brain | Alphanumeric |
Choose all that apply |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 11:47:38.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C59106 | Surgery head fixation status | SurgHeadFixationStatus | Status of the participant's/subject's head fixation to the operating room table during surgery | Status of the participant's/subject's head fixation to the operating room table during surgery | Head fixation to operating room table | Yes, specify;None | Yes, specify;None | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:42:27.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59121 | Brain lead cylindrical type other text | BrainLeadCylindricalTypOTH | The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted | The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted | Cylindrical-other | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:20:42.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C02411 | Laterality type | LatTyp | Laterality type relative to the anatomic site of the body examined or affected | Laterality type relative to the anatomic site of the body examined or affected | Structure targeted | Left;Right | Left;Right | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59154 | Brain lead replacement manipulation count | BrainLeadRplcmntMnpltnCt | Count of brain leads replaced or manipulated | Count of brain leads replaced or manipulated | If yes, how many | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:21:12.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C18758 | Surgery post-operative target verification method source other text | SurgPstOpTrgtVrfMethdSourceOTH | The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached | The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached | Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the method used for post-operative target verification |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:47:16.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59132 | Stimulation brain parameter directional steering indicator | StimBrainParamDirectnlStrngInd | Indicator related to whether directional steering was used in the brain stimulation parameters | Indicator related to whether directional steering was used in the brain stimulation parameters | Directional steering used? | No;Yes | No;Yes | Alphanumeric |
Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:33:05.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08036 | Stereotactic surgery mini-frame type | StereotactSurgMiniFrmTyp | Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surgery | Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surger | If mini-frame is checked, specify the following | Medtronic Nexframe;FHC Starfix;MRI interventions SmartFrame;Other, specify | Medtronic Nexframe;FHC Starfix;MRI interventions SmartFrame;Other, specify | Alphanumeric |
Only answer if 'mini-frame' is answered for 'Frame Type'. |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 17:48:58.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C59587 | Surgery procedure hour duration | SurgeryProcedureHourDur | Duration in hours of surgery or procedure | Duration in hours of surgery or procedure | Total surgical time (incision to closure): hours | Numeric Values |
Time from incision to closure reported in hours |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:01:53.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hour | |||||||||
| C59092 | Unified Parkinsons Disease Rating Scale version type | UPDRSVerTyp | Type of version of the Unified Parkinson's Disease Rating Scale (UPDRS) administered | Type of version of the Unified Parkinson's Disease Rating Scale (UPDRS) administered | Version of UPDRS administered | MDS-UPDRS;UPDRS | MDS-UPDRS;UPDRS | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:28:29.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59144 | Brain lead post implant interval | BrainLeadPostImplantIntrvl | Interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented | Interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented | Number of weeks/months post implantation that these stimulation and parameters and clinical motor outcomes were documented | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:57:50.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08064 | Lead reposition reason | LeadRepositRsn | Reason the lead was repositioned in the participant/subject | Reason the lead was repositioned in the participant/subject | Select reason lead repositioned | Poor initial positioning;Migration of lead from initial position;Lead fracture or electrical malfunction;Other, specify | Poor initial positioning;Migration of lead from initial position;Lead fracture or electrical malfunction;Other, specify | Alphanumeric |
For reason other than infection. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:04:55.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59107 | Surgery head fixation text | SurgHeadFixationTxt | The free-text field to specify the head fixation to the operating room table used for the subject/participant during surgery | The free-text field to specify the head fixation to the operating room table used for the subject/participant during surgery | Yes, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:44:49.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59122 | Brain lead intercontact space interval type | BrainLdIntcntctSpcIntrvlTyp | Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) | Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) | Intercontact spacing (between ends of contacts, not centers) | 0.5 mm;1.5 mm;3 mm;Other, specify | 0.5 mm;1.5 mm;3 mm;Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:21:25.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C05106 | Surgical therapeutic procedure start date and time | SurgTherapuProcStartDateTime | Date (and time, if applicable and known) on which the surgical or therapeutic procedure started | Date (and time, if applicable and known) on which the surgical or therapeutic procedure started | Neurosurgery date | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
No references available | Adult | Supplemental | 3.20 | 2022-08-18 17:27:56.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59155 | Pulse generator replacement manipulation count | PulseGeneratorRplcmntMnpltnCt | Count of pulse generators replaced or manipulated | Count of pulse generators replaced or manipulated | If yes, how many | Numeric Values |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:22:07.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C18760 | Surgery skull opening type other text | SurgSkulOpngTypOTH | The free-text field related to 'Surgery skull opening type', specifying other text. Type of drilling or perforation of the skull in order to get access to the brain | The free-text field related to 'Surgery skull opening type', specifying other text. Type of drilling or perforation of the skull in order to get access to the brain | Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of drilling or perforation of the skull in order to get access to the brain |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:44:35.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59133 | Stimulation brain parameter amplitude value | StimBrainParamAmpVal | Value of the amplitude of electric pulses (stimulation) on brain hemisphere | Value of the amplitude of electric pulses (stimulation) on brain hemisphere | Amplitude | Numeric Values |
This value should be answered in Volts or milliampere (mA). Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:34:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08037 | Surgery skull opening type | SurgSkulOpngTyp | Type of drilling or perforation of the skull in order to get access to the brain | Type of drilling or perforation of the skull in order to get access to the brain | Type of Opening | Burr hole;Twist drill hole;Other, specify | Burr hole;Twist drill hole;Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of drilling or perforation of the skull in order to get access to the brain |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59588 | Anterior commissure posterior commissure target x coordinate value | ACPCTrgtXCoordVal | Stereotactic x coordinate with respect to anterior and posterior commissure (brain nuclei) | Stereotactic x coordinate with respect to anterior and posterior commissure (brain nuclei) | AC-PC coordinates for lead tip with respect to midcommissural point (positive values are right, anterior, and superior, negative values are left, posterior, and inferior) x | Numeric Values |
Specify left and right coordinates if procedure is unilateral. Positive values are right, anterior, and superior, negative values are left, posterior, and inferior |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:03:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59094 | Unified Parkinsons Disease Rating Scale part three off levodopa score | UPDRSPartThreeOffLevodopaScore | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is off of levodopa | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is off of levodopa | UPDRS part 3 score, off levodopa | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:30:49.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59145 | Brain lead post implant interval unit of measure | BrainLeadPostImplantIntrvlUOM | Unit of measure for the interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented | Unit of measure for the interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented | Number of weeks/months post implantation that these stimulation and parameters and clinical motor outcomes were documented | Week;Month | Week;Month | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:58:39.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08065 | Surgical complication category | SurgComplicCat | Category of the surgical complication experienced by the participant/subject | Category of the surgical complication experienced by the participant/subject | Complications not directly involving hardware | Intra-Operative;Post-Operative;N/A | Intra-Operative;Post-Operative;N/A | Alphanumeric |
Within 3 months of implantation. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 11:48:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59108 | Stereotactic surgery robotic guidance lead insert indicator | StereotactSrgRbtcGdncLdInstInd | Indicator of whether robotic guidance was used during stereotactic surgery for lead insertion | Indicator of whether robotic guidance was used during stereotactic surgery for lead insertion | Robotic guidance | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:45:41.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59123 | Brain lead intercontact space interval type other text | BrainLdIntcntctSpcIntrvlTypOTH | The free-text field related to 'Brain lead intercontact space interval type', specifying other text. Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) | The free-text field related to 'Brain lead intercontact space interval type', specifying other text. Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:24:02.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C08017 | Case report number | CaseRprtNum | Although not a data item, the case report number may be helpful for centers to track and enumerate the number of PD DBS surgeries performed | Although not a data item, the case report number may be helpful for centers to track and enumerate the number of PD DBS surgeries performed | Case report | Alphanumeric |
If known, please give the case report number |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59156 | Pulse generator replacement reason | PulseGeneratorRplcmntRsn | The reason the pulse generator was replaced | The reason the pulse generator was replaced | Select reason for pulse generator replacement | Electrical malfunction;Rechargeable pulse generator flipped over and cannot be recharged;Discomfort;Other, specify | Electrical malfunction;Rechargeable pulse generator flipped over and cannot be recharged;Discomfort;Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:22:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C18761 | Surgical complication intra-operative type other text | SurgComplicIntraOpTypOTH | The free-text field related to 'Surgical complications intra-operative type', specifying other text. Type of intra-operative surgical complications experienced by the participant/subject | The free-text field related to 'Surgical complications intra-operative type', specifying other text. Type of intra-operative surgical complications experienced by the participant/subject | Other, specify | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:49:54.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59134 | Stimulation brain parameter amplitude unit of measure | StimBrainParamAmpUOM | Unit of measure for amplitude of electric impulses (stimulation) on brain hemisphere | Unit of measure for amplitude of electric impulses (stimulation) on brain hemisphere | Amplitude | mA;Volts | milliampere;Volts | Alphanumeric |
Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:34:49.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08038 | Surgery intra-operative target verification source | SurgIntraOpTrgtVerifSource | Intra-operative source method used for verifying the target of the surgery | Intra-operative source method used for verifying the target of the surgery | Intra-operative target verification | Fluoroscopy;CT or cone beam CT;Microelectrode recording and/or microstimulation;Test stimulation through DBS lead or other microcontact;MRI | Fluoroscopy;CT or cone beam CT;Microelectrode recording and/or microstimulation;Test stimulation through DBS lead or other microcontact;MRI | Alphanumeric |
Check all that apply |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 17:45:23.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C59589 | Anterior commissure posterior commissure target y coordinate value | ACPCTrgtYCoordVal | Stereotactic y coordinate with respect to anterior and posterior commissure (brain nuclei) | Stereotactic y coordinate with respect to anterior and posterior commissure (brain nuclei) | AC-PC coordinates for lead tip with respect to midcommissural point (positive values are right, anterior, and superior, negative values are left, posterior, and inferior) y | Numeric Values |
Specify left and right coordinates if procedure is unilateral. Positive values are right, anterior, and superior, negative values are left, posterior, and inferior |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:03:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59095 | L-Dopa pre-operative challenge off levodopa duration | LDopaPreOpChllngOffLevodopaDur | Duration in hours the participant/subject was off of levodopa as part of the pre-operative L-Dopa challenge | Duration in hours the participant/subject was off of levodopa as part of the pre-operative L-Dopa challenge | Hours of off levodopa | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:31:52.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hour | |||||||||
| C59146 | Surgical complication hemorrhage symptom status | SurgComplicHemorrhgSymptmStat | Status of hemorrhage symptoms related to intra-operative or post-operative surgical complications | Status of hemorrhage symptoms related to intra-operative or post-operative surgical complications | Hemorrhage If yes | Symptomatic;Asymptomatic | Symptomatic;Asymptomatic | Alphanumeric |
Answer if 'Hemorrhage' is selected as an intra-operative or post-operative surgical complication type |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:03:13.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08066 | Surgical complication intra-operative type | SurgComplicIntraOpTyp | Type of intra-operative surgical complications experienced by the participant/subject | Type of intra-operative surgical complications experienced by the participant/subject | Intra-operative | Hemorrhage;Seizure;Change of mental status;Other, specify;Cardiovascular event (e.g., arrhythmia, heart attack, etc.);Procedure aborted | Hemorrhage;Seizure;Change of mental status;Other, specify;Cardiovascular event (e.g., arrhythmia, heart attack, etc.);Procedure aborted | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 11:48:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59109 | Stereotactic surgery robotic guidance lead insert platform text | StertctSrgRbtGdnLdInstPlfmTxt | The free-text field related to the robotic guidance platform used during stereotactic surgery for lead insertion | The free-text field related to the robotic guidance platform used during stereotactic surgery for lead insertion | If yes, specify platform | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:47:04.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59124 | Device model name | DevModelName | The name of the model of the device | The name of the model of the device | Lead model | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:17.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08018 | Surgery age value | SurgAgeVal | Age of the participant/subject at the time of the selected surgical procedure | Age of the participant/subject at the time of the selected surgical procedure | Age at time of surgery | Numeric Values |
This element is not considered Core. Please refer to the Date of Birth element on the General Demographics form to derive age. If age is necessary to capture on this form, it may be added. |
No references available | Adult | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C59158 | Pulse generator replacement reason other text | PulseGeneratorRplcmntRsnOTH | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:27:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C18763 | Surgical complication post-operative type other text | SurgComplicPstOpTypOTH | The free-text field related to 'Surgical complications post-operative type', specifying other text. Type of post-operative surgical complications experienced by the participant/subject | The free-text field related to 'Surgical complications post-operative type', specifying other text. Type of post-operative surgical complications experienced by the participant/subject | Other, specify | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:52:18.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59135 | Stimulation brain parameter frequency value | StimBrainParamFreqVal | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Frequency: Hz | Numeric Values |
This value should be answered in Hertz (Hz). Answer for both left brain and right brain, if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:37:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hertz | |||||||||
| C08039 | Electrode brain count | ElectrdBrainCt | Count of electrodes introduced in the brain | Count of electrodes introduced in the brain | Number of microelectrodes passed simultaneously | Numeric Values |
Only answer if 'Simultaneous multiple-microelectrode recording' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 4.00 | 2017-04-12 00:00:00.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C59590 | Anterior commissure posterior commissure target z coordinate value | ACPCTrgtZCoordVal | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | AC-PC coordinates for lead tip with respect to midcommissural point (positive values are right, anterior, and superior, negative values are left, posterior, and inferior) z | Numeric Values |
Specify left and right coordinates if procedure is unilateral. Positive values are right, anterior, and superior, negative values are left, posterior, and inferior |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:03:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
