CDE Detailed Report

Disease: Parkinson's Disease
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
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

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

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

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

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

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
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.
If 'mini-frame' is checked, specify the type

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

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

C08051 Stimulation parameter brain hemisphere type StimParamBrainHemisphTyp Side of the brain targeted for stimulation Side of the brain targeted for stimulation Left Brain Right Brain Right;Left Right Brain;Left Brain Alphanumeric

Choose all that apply

No references available Adult Supplemental 3.10 2022-07-29 11:47:38.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C59106 Surgery head fixation status SurgHeadFixationStatus Status of the participant's/subject's head fixation to the operating room table during surgery Status of the participant's/subject's head fixation to the operating room table during surgery Head fixation to operating room table Yes, specify;None Yes, specify;None Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 09:42:27.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C59143 Unified Parkinsons Disease Rating Scale part three on DBS on medication score UPDRSPtThreeOnDBSOnMedScore The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications UPDRS part 3 score, on DBS, on medication Numeric Values

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:57:03.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C59154 Brain lead replacement manipulation count BrainLeadRplcmntMnpltnCt Count of brain leads replaced or manipulated Count of brain leads replaced or manipulated If yes, how many Numeric Values

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 11:21:12.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C18758 Surgery post-operative target verification method source other text SurgPstOpTrgtVrfMethdSourceOTH The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached Other, specify Alphanumeric

Using the options listed, or free text, please specify the method used for post-operative target verification

No references available Adult Supplemental 1.10 2022-07-29 11:47:16.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C59121 Brain lead cylindrical type other text BrainLeadCylindricalTypOTH The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted Cylindrical-other Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:20:42.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Structure targeted Left;Right Left;Right Alphanumeric

No instructions available

No references available Adult Supplemental 3.00 2013-08-28 16:08:00.453 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

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'.
Check all that apply

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

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

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

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.
Choose only one

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

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

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

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

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

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

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

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

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

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

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

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

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.
In order to prevent duplication of data collection, the General Adverse Event form will be considered Core for clinical trials. If the information on that form does not completely capture what is needed, the surgical complications section can be supplemental.
If N/A, go to question on hardware-related complications

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

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

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

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

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

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

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

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

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

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

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

CSV