CDE Detailed Report
Disease: system
Subdomain Name: Surgeries and Other Procedures
CRF: files
Displaying 1 - 50 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: files
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59113 | Microelectrode record type | MicroelectrdRecTyp | Type of microelectrode recording done for intra-operative target verification | Type of microelectrode recording done for intra-operative target verification | Microelectrode recording and/or microstimulation | Serial single microelectrode recording;Simultaneous multiple-microelectrode recording | Serial single microelectrode recording;Simultaneous multiple-microelectrode recording | 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 09:57:43.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59149 | Surgical complication hardware related type | SurgComplicHrdwrRelatedTyp | Type of hardware related surgical complication experienced by the participant/subject | Type of hardware related surgical complication experienced by the participant/subject | Hardware-related complications | Further surgery for replacement or manipulation of a brain lead (for reason other than infection);Further surgery for replacement or manipulation of lead extender (for reason other than infection);Further surgery for replacement or manipulation of pulse generator (for reason other than infection);Hardware infection requiring further surgery for removal of hardware components;N/A | Further surgery for replacement or manipulation of a brain lead (for reason other than infection);Further surgery for replacement or manipulation of lead extender (for reason other than infection);Further surgery for replacement or manipulation of pulse generator (for reason other than infection);Hardware infection requiring further surgery for removal of hardware components;N/A | Alphanumeric |
Within three months of implantation |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:07:37.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C18681 | Functional neurosurgery target anatomic site other text | FuncNeurosurgTrgtAnatSiteOTH | The free-text field related to 'Functional neurosurgery target anatomic site', specifying other text. The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | The free-text field related to 'Functional neurosurgery target anatomic site', specifying other text. The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:41:32.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59127 | Pulse generator sensing function indicator | PulseGeneratorSnsngFunctionInd | Indicator of whether the pulse generator inserted has sensing function | Indicator of whether the pulse generator inserted has sensing function | Pulse generator has sensing function? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:28:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C08026 | Functional neurosurgery target anatomic site | FuncNeurosurgTrgtAnatSite | The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | Structure targeted | Subthalamic Nucleus (STN);Other, specify;Ventrolateral thalamus;None;Multiple ipsilateral leads, specify;Globus Pallidus;Pedunculopontine nucleus (PPN) | Subthalamic Nucleus (STN);Other, specify;Ventrolateral thalamus;None;Multiple ipsilateral leads, specify;Globus Pallidus;Pedunculopontine nucleus (PPN) | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:07:26.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59162 | Lead extender replacement reason other text | LeadExtndrRplcmntRsnOTH | The free-text field related to 'Lead extender replacement reason', specifying other text. The reason the lead extender was replaced | The free-text field related to 'Lead extender replacement reason', specifying other text. The reason the lead extender was replaced | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:30:28.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59086 | Motor fluctuation year duration | MotorFluctuationYrDur | Duration in years of motor fluctuations at the time of surgery | Duration in years of motor fluctuations at the time of surgery | Duration of motor fluctuations: years | Numeric Values |
Specify zero if none. This value should be captured in years |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:09:24.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
year | |||||||||
| C59138 | Stimulation brain paradigm type other text | StimBrainParadigmTypOTH | The free-text field related to 'Stimulation brain paradigm type', specifying other text. Type of brain stimulation paradigm | The free-text field related to 'Stimulation brain paradigm type', specifying other text. Type of brain stimulation paradigm | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:42:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C08042 | Surgery externalization use indicator | SurgExtrnlUseInd | Indicator of whether a procedure of exposing the implanted electrodes out of the brain for stimulation purposes was performed | Indicator of whether a procedure of exposing the implanted electrodes out of the brain for stimulation purposes was performed | Use of lead externalization | Yes;No | Yes;No | Alphanumeric |
Choose only one |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:17:15.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59100 | Functional neurosurgery target anatomic site multiple ipsilateral lead specify text | FnNsrgTgtAntSteMltIpltlLdSpTxt | The free-text field to specify the anatomic site targets when multiple ipsilateral leads are used in functional neurosurgery procedure | The free-text field to specify the anatomic site targets when multiple ipsilateral leads are used in functional neurosurgery procedure | Multiple ipsilateral leads, specify | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:34:37.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C59115 | Test stimulation sedation type | TestStimulationSedationTyp | Type of sedation used during test stimulation through deep brain stimulation (DBS) lead or other microcontact used during intra-operative target verification | Type of sedation used during test stimulation through deep brain stimulation (DBS) lead or other microcontact used during intra-operative target verification | Test stimulation through DBS lead or other microcontact | No sedation;Light sedation;Gen anesthesia | No sedation;Light sedation;Gen anesthesia | Alphanumeric |
Only answer if 'Test stimulation through DBS lead or other microcontact' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:00:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59150 | Hardware component remove type | HrdwrCompRemoveTyp | Type of hardware component removed | Type of hardware component removed | Component removed | Brain lead;IPG;Lead extender | Brain lead;IPG;Lead extender | Alphanumeric |
Specify number of hardware components removed as applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:11:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
||||||||
| C18682 | Functional neurosurgery target planning method type other text | FuncNrsrgTrgtPlnngMethdTypOTH | The free-text field related to 'Functional neurosurgery target planning method type', specifying other text. The type of method used to determine the coordinates of the target (brain nucleus) | The free-text field related to 'Functional neurosurgery target planning method type', specifying other text. The type of method used to determine the coordinates of the target (brain nucleus) | Other targeting methods, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of method used to determine the coordinates of the target (brain nucleus) |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:42:56.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59128 | Imaging processing software name | ImgProcessSftwrName | Name of the software used for imaging processing | Name of the software used for imaging processing | Software utilized for image processing if any (for example LeadDBS, Brainlab Elements, etc.) | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:30:20.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C08031 | Functional neurosurgery target planning method type | FuncNeurosurgTrgtPlnngMethdTyp | The type of method used to determine the coordinates of the target (brain nucleus) | The type of method used to determine the coordinates of the target (brain nucleus) | Target planning method | Direct targeting on MRI;Indirect targeting on MRI;Indirect targeting on CT;Surgical planning software;Surgical planning adjuncts;Other targeting methods, specify | Direct targeting on MRI;Indirect targeting on MRI;Indirect targeting on CT;Surgical planning software;Surgical planning adjuncts;Other targeting methods, specify | Alphanumeric |
Check all that apply |
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 |
Multiple Pre-Defined Values Selected |
||||||||
| C59583 | Parkinsons disease motor sign month duration | ParkinsonsDiseaseMotorSgnMoDur | Duration in months of motor signs related to Parkinson's disease at the time of surgery | Duration in months of motor signs related to Parkinson's disease at the time of surgery | Duration of motor signs of Parkinson's disease: months | Numeric Values |
This value should be captured in months |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:06:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
month | |||||||||
| C59087 | Dyskinesia troublesome year duration | DyskinesiaTroublesomeYrDur | Duration in years of troublesome dyskinesias at the time of surgery | Duration in years of troublesome dyskinesias at the time of surgery | Duration of troublesome dyskinesias: years | Numeric Values |
Specify zero if none. This value should be captured in years |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:10:35.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
year | |||||||||
| C59101 | Functional neurosurgery target planning software type text | FuncNrsrgTrgtPlnngSftwrTypTxt | The free-text field to describe the type of functional neurosurgery target planning software used to determine the coordinates of the target (brain nucleus) | The free-text field to describe the type of functional neurosurgery target planning software used to determine the coordinates of the target (brain nucleus) | Surgical planning software type | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:35:13.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C59139 | Optimal programming limit stimulation adverse effect indicator | OptmlPrgmgLmtStmAdvrsEfctInd | Indicator related to whether optimal programming is limited by stimulation-induced adverse effects | Indicator related to whether optimal programming is limited by stimulation-induced adverse effects | Optimal programming limited by stimulation-induced adverse effects | Yes, specify;No | Yes, specify;No | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:43:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C08045 | Surgery post-operative target verification method source | SurgPstOpTrgtVerifMethdSource | Post-operative source method used for verifying the brain nucleus (target) was reached | Post-operative source method used for verifying the brain nucleus (target) was reached | Modality | CT;MRI;Other, specify | CT;MRI;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 | 3.10 | 2022-07-29 12:09:00.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
||||||||
| C59117 | Brain lead insert count | BrainLeadInsertCt | Count of brain leads inserted | Count of brain leads inserted | Number of brain leads inserted | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:14:11.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
||||||||||
| C02302 | Adverse event other action taken type | AdvEvntOthrActionTakenTyp | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Action Taken | None;Treatment required, specify | None;Treatment required, specify | Alphanumeric |
Choose one. If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF. |
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 |
3141322 | |||||||
| C59151 | Brain lead remove count | BrainLeadRemoveCt | Count of brain leads removed | Count of brain leads removed | Brain lead (specify # of leads removed) | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:16:39.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
||||||||||
| C18734 | Lead reposition reason other text | LeadRepositRsnOTH | The free-text field related to 'Lead reposition reason', specifying other text. Reason the lead was repositioned in the participant/subject | The free-text field related to 'Lead reposition reason', specifying other text. Reason the lead was repositioned in the participant/subject | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:53:27.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59129 | Stimulation brain parameter contact configuration text | StimBrainParamContactConfigTxt | Text related to contact configuration brain stimulation parameters | Text related to contact configuration brain stimulation parameters | Contact configuration | Alphanumeric |
Include percent activation if applicable. Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:30:58.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C08033 | Medication anti-Parkinsonian during procedure indicator | MedAntiPrknsnDurngProcInd | Indicator of whether the participant/subject was on anti-Parkinsonian medication(s) during the surgical procedure | Indicator of whether the participant/subject was on anti-Parkinsonian medication(s) during the surgical procedure | Was patient on anti-Parkinsonian medication(s) during procedure | Yes;No | Yes;No | Alphanumeric |
Choose only one |
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 |
||||||||
| C59584 | Motor fluctuation month duration | MotorFluctuationMoDur | Duration in months of motor fluctuations at the time of surgery | Duration in months of motor fluctuations at the time of surgery | Duration of motor fluctuations: months | Numeric Values |
Specify zero if none. This value should be captured in months |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:09:24.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
month | |||||||||
| C59088 | Deep brain stimulation indication type | DBSIndicationTyp | Type of indications for deep brain stimulation (DBS) | Type of indications for deep brain stimulation (DBS) | Indication(s) for DBS | Motor fluctuations;Other indication, specify;Medication-induced dyskinesia;Medication-resistant tremor;Other medication side effects, specify | Motor fluctuations;Other indication, specify;Medication-induced dyskinesia;Medication-resistant tremor;Other medication side effects, specify | Alphanumeric |
Check all that apply |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:11:52.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
||||||||
| C59103 | Functional neurosurgery target planning adjunct type | FuncNeurosrgTrgtPlnngAdjnctTyp | Type of functional neurosurgery planning adjuncts used to determine the coordinates of the target (brain nucleus) | Type of functional neurosurgery planning adjuncts used to determine the coordinates of the target (brain nucleus) | Surgical planning adjuncts | Tractography;Automated segmentation of nuclei | Tractography;Automated segmentation of nuclei | Alphanumeric |
Check all that apply |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:35:56.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
||||||||
| C59140 | Optimal programming limit stimulation adverse effect indicator specify text | OptmlPrgmgLmtStmAdvrsEfctSpTxt | The free-text field related to 'Optimal programming limit stimulation adverse effect indicator', specifying details if the response is 'Yes' | The free-text field related to 'Optimal programming limit stimulation adverse effect indicator', specifying details if the response is 'Yes' | Yes, specify | Alphanumeric |
Only answer if Yes is selected for the previous question |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:45:07.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C08046 | Medication anti-Parkinsonian reduced after surgery indicator | MedAntiPrknsnRedAftrSurgInd | Indicator of whether anti-Parkinsonism medication(s) were reduced following optimization (X weeks after surgery) | Indicator of whether anti-Parkinsonism medication(s) were reduced following optimization (X weeks after surgery | Following optimization at the stimulation parameters above, were anti-Parkinsonism medications reduced compared to preoperative baseline? | No;Yes, % reduction in levodopa equivalents | No;Yes, % reduction in levodopa equivalents | Alphanumeric |
Choose ony one |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:09:28.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59118 | Brain lead type | BrainLeadTyp | Type of brain lead inserted | Type of brain lead inserted | Brain lead(s) | Directional-other;Directional-8 contact;Cylindrical-4 contact;Cylindrical-8 contact;Cylindrical-other | Directional-other;Directional-8 contact;Cylindrical-4 contact;Cylindrical-8 contact;Cylindrical-other | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:15:41.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C02303 | Adverse event outcome status | AdvrsEvntOutcomStatus | Final status of the participant/subject related to the adverse event | Final status of the participant/subject related to the adverse event | Complication outcome (at three months) | Recovered/resolved without neurological deficit;Produced persistent neurological deficit;Other | Recovered/resolved without neurological deficit;Produced persistent neurological deficit;Other | Alphanumeric |
Choose one outcome at three months |
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 |
2746517 | |||||||
| C59152 | Implantable pulse generator remove count | IPGRemoveCT | Count of implantable pulse generators (IPGs) removed | Count of implantable pulse generators (IPGs) removed | IPG (specify # of IPGs removed) | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:17:29.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
||||||||||
| C18755 | Stereotactic surgery frame type other text | StereostactSurgFrmTypOTH | The free-text field related to 'Stereotactic surgery frame type', specifying other text. Scaffold or support used for stereotactic surgery | The free-text field related to 'Stereotactic surgery frame type,' specifying other text. Scaffold or support used for stereotactic surgery | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:43:48.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59130 | Stimulation brain parameter negative contact text | StimBrainParamNegtveContactTxt | Text related to negative contact brain stimulation parameters | Text related to negative contact brain stimulation parameters | Negative contact(s) | Alphanumeric |
Answer for both left brain and right brain if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:31:39.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C08034 | Surgery head position status | SurgHeadPositStatus | Status of the participant's/subject's head position with respect to the horizontal plane during surgery | Status of the participant's/subject's head position with respect to the horizontal plane during surgery | Head position | Head of bed elevated;Head of bed flat | Head of bed elevated;Head of bed flat | Alphanumeric |
Choose only one |
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 |
||||||||
| C59585 | Dyskinesia troublesome month duration | DyskinesiaTroublesomeMoDur | Duration in months of troublesome dyskinesias at the time of surgery | Duration in months of troublesome dyskinesias at the time of surgery | Duration of troublesome dyskinesias: months | Numeric Values |
Specify zero if none. This value should be captured in months |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:10:35.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
month | |||||||||
| C59089 | Deep brain stimulation indication type medication side effect other text | DBSIndctnTypMedctnSdeEffctOTH | The free text field related to 'Deep brain stimulation indication type', specifying other medication side effects | The free text field related to 'Deep brain stimulation indication type', specifying other medication side effects | Other medication side effects, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:23:46.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| C59105 | Anesthesia type | AnesthTyp | Type of anesthesia given to the participant/subject | Type of anesthesia given to the participant/subject | Type of anesthesia | General;Local only;Moderate sedation | General;Local only;Moderate sedation | Alphanumeric |
For lead placement surgery |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:39:30.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
||||||||
| C59142 | Unified Parkinsons Disease Rating Scale part three on DBS off medication score | UPDRSPtThreeOnDBSOffMedScore | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and off medications | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and off medications | UPDRS part 3 score, on DBS, off medication | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:45:57.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
||||||||||
| C08047 | Medication anti-Parkinsonian reduced after surgery percent value | MedAntiPrknsnRdAftrSurgPrctVal | Percent anti-Parkinsonism medication(s) were reduced | Percent anti-Parkinsonism medication(s) were reduced | Yes, % reduction in levodopa equivalents | Numeric Values |
Only answered if Yes is selected for the previous question |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:10:35.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
||||||||||
| C59120 | Brain lead directional type other text | BrainLeadDirectionalTypOTH | The free-text field related to 'Brain lead type', specifying the other type of directional lead inserted | The free-text field related to 'Brain lead type', specifying the other type of directional lead inserted | Directional-other | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:19:50.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
|||||||||
| 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 |
||||||||||
| 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 |
|||||||||
| 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 |
|||||||||
| 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 |
||||||||
| 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 |
|||||||||
| 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 |
