CDE Detailed Report
Disease: Parkinson's Disease
Subdomain Name: Surgeries and Other Procedures
CRF: Functional Neurosurgery: Deep Brain Stimulation
Displaying 1 - 50 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: Functional Neurosurgery: Deep Brain Stimulation
Displaying 1 - 50 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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 | |||||||||
| 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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| 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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| 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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| 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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| 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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| 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 |
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| C59096 | L-Dopa pre-operative challenge off dopamine agonist duration | LDopaPreOpChllngOffDpmAgnstDur | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Hours of off dopamine agonists | Numeric Values |
Specify which agonists |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:32:41.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hour | |||||||||
| 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 | ||||||||
| C08067 | Surgical complication post-operative type | SurgComplicPstOpTyp | Type of post-operative surgical complications experienced by the participant/subject | Type of post-operative surgical complications experienced by the participant/subject | Post-operative | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | 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 11:50:23.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59110 | Surgery intra-operative target verify lead placement MRI type | SurgIntraOpTrgtVrfLdPlcmMRITyp | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | MRI | In surgical suite immediately following lead placement;Real time during placement | In surgical suite immediately following lead placement;Real time during placement | Alphanumeric |
Only answer if 'MRI' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:47:46.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59147 | Adverse event treatment specify text | AdvEvntTreatmtSpecifyTxt | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | Treatment required, specify | Alphanumeric |
If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:06:04.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C54898 | Surgery procedure minute duration | SurgeryProcedureMinuteDur | Duration in minutes of surgery or procedure | Duration in minutes of surgery or procedure | Total surgical time (incision to closure): minutes | Numeric Values |
Time from incision to closure reported in minutes |
No references available | Adult | Supplemental | 1.10 | 2022-08-18 17:01:53.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
minute | |||||||||
| C59125 | Pulse generator insert count | PulseGeneratorInsertCt | Count of pulse generators inserted | Count of pulse generators inserted | Number of pulse generators inserted | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:58.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08022 | Imaging magnetic resonance imaging findings result status | ImgMRIFndngResltStat | Results from MRI studies | Results from MRI studies indicator | MRI findings | Abnormal;Normal | Abnormal;Normal | Alphanumeric |
Choose only one |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 11:39:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59159 | Lead extender replacement manipulation count | LeadExtndrRplcmntMnpltnCt | Count of brain lead extenders replaced or manipulated during further surgery | Count of brain lead extenders replaced or manipulated during further surgery | Other, specify | Numeric Values |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:28:03.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59097 | Dopamine agonist specify text | DopamineAgonistSpecifyTxt | The free-text field to specify the dopamine agonist taken by the participant/subject | The free-text field to specify the dopamine agonist taken by the participant/subject | Specify which agonists | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:33:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59136 | Stimulation brain parameter pulse width value | StimBrainParamPlsWdthVal | Value of the width of electric pulses (stimulation) on brain hemisphere | Value of the width of electric pulses (stimulation) on brain hemisphere | Pulse Width: microsec | Numeric Values |
This value should be answered in microseconds (?sec). Answer for both left brain and right brain, if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:38:17.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
microseconds | |||||||||
| C08040 | Microelectrode pass count | MicrelectrdPssCt | Count of times the microelectrode is passed through the brain | Count of times the microelectrode is passed through the brain | Number of electrode penetrations | Numeric Values |
Only answer if 'Serial single microelectrode recording' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 11:45:30.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
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| C14517 | Device manufacturer name | DevManufName | The company responsible for development of the device | The name of the manufacturer of the device that was placed in the subject's body | Lead manufacturer | 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 | 255 |
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| C59111 | Microelectrode record microstimulation sedation type | MicrlctrdRecMicrstimltnSedTyp | Type of sedation used during microelectrode recording or microstimulation for intra-operative target verification | Type of sedation used during microelectrode recording or microstimulation for intra-operative target verification | Microelectrode recording and/or microstimulation | No sedation;Light sedation;Gen anesthesia | No sedation;Light sedation;Gen anesthesia | Alphanumeric |
Only answer if 'Microelectrode recording and/or microstimulation' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:49:39.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59148 | Adverse event outcome status other text | AdvrsEvntOutcomStatusOTH | The free-text field related to 'Adverse event outcome status', specifying other text. Final status of the participant/subject related to the adverse event | The free-text field related to 'Adverse event outcome status', specifying other text. Final status of the participant/subject related to the adverse event | Other | Alphanumeric |
Complication outcome (at three months) |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:06:42.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
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