CDE Detailed Report

Disease: content
Subdomain Name: Surgeries and Other Procedures
CRF: welcome

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
C59126 Pulse generator battery type PulseGeneratorBatteryTyp Type of battery used in the pulse generator(s) inserted Type of battery used in the pulse generator(s) inserted Number of pulse generators inserted Rechargeable;Primary cell Rechargeable;Primary cell Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:26:46.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08023 Imaging abnormal finding text ImgAbnrmlFindTxt Text description of the abnormal findings on the imaging study Text description of the abnormal findings on the imaging study If Abnormal, comment Alphanumeric

Only answered if 'Abnormal' is answered for the previous question

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 255

Free-Form Entry

C59160 Lead extender replacement reason LeadExtndrRplcmntRsn The reason the lead extender was replaced The reason the lead extender was replaced Select reason for lead extender replacement Electrical malfunction;Discomfort;Other, specify Electrical malfunction;Discomfort;Other, specify Alphanumeric

For reason other than infection

No references available Adult Supplemental 1.00 2022-07-28 11:28:37.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C59085 Parkinsons disease motor sign year duration ParkinsonsDiseaseMotorSgnYrDur Duration in years of motor signs related to Parkinson's disease at the time of surgery Duration in years of motor signs related to Parkinson's disease at the time of surgery Duration of motor signs of Parkinson's disease: years Numeric Values

This value should be captured in years

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

year
C59137 Stimulation brain paradigm type StimBrainParadigmTyp Type of brain stimulation paradigm Type of brain stimulation paradigm Stimulation paradigms, specify Constant stimulation;Adaptive DBS;Coordinated reset;Other, specify Constant stimulation;Adaptive DBS;Coordinated reset;Other, specify Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:39:04.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08041 Surgery lead secure method type SurgLeadSecurMethdTyp 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 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 Method to secure lead Mini-plate;Manufacturer's specific locking device;Other, specify Mini-plate;Manufacturer's specific locking device;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 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

C59099 Unified Parkinsons Disease Rating Scale part three on medication score UPDRSPartThreeOnMedctnScore The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on medications The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on medications UPDRS part 3 score, on medications Numeric Values

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 09:33:54.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

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

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

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

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

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

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
Using the options listed, or free text, please specify the type of method used to determine the coordinates of the target (brain nucleus)
'Indirect' refers to use of standard coordinates from mid-commissural point or other reference point

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
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

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

C02302 Adverse event other action take type AdvEvntOthrActionTakeTyp 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 3.1 10/16/2024 8:51:11 AM 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

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

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

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

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

C02303 Adverse event outcome status AdvrsEvntOutcomStatus Final status of the participant related to the adverse event Final status of the participant 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 3.1 10/16/2024 8:51:11 AM 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

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

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

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

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

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
CSV