CDE Detailed Report

Disease: Parkinson's Disease
Sub-Domain: Surgeries and Other Procedures
CRF: Functional Neurosurgery

Displaying 1 - 50 of 79
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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C08024 L-Dopa pre-operative stim-on time LDOPAPreOpStmonTime The pre-operative stimulation start (or on) time of the L-Dopa challenge response The pre-operative stimulation start (or on) time of the L-Dopa challenge response L-DOPA challenge responses Stim on time Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08057 L-Dopa post-operative stim - on time LDOPAPstOpStimonTime Post-operative stimulation start (or on) time of the L-Dopa challenge response Post-operative stimulation start (or on) time of the L-Dopa challenge response L DOPA challenge responses Stim on time Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C18761 Surgical complications intra-operative other text SurgComplicIntraOpOTH 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

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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08036 Stereotactic surgery mini-frame type StereostatSurgMiniFrmTyp 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 surgery. If mini frame is checked, specify the following Medtronic;FHC Medtronic;FHC Alphanumeric

Only answer if 'Mini-frame' is answered for 'Frame Type'

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08068 Surgical complications post-operative mechanical malfunction type SurgComplicPstOpMechMalfTyp Type of post-operative mechanical malfunction experienced by the participant/subject Type of post-operative mechanical malfunction experienced by the participant/subject Post Operative Mechanical Malfunction Electrode;Device;Other, specify Electrode;Device;Other, specify Alphanumeric

Choose only one. If there are multiple complications, refer to the General Adverse Events form for reporting instructions. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C02305 Adverse event severity grade scale AdvrsEvntSeverScale The grading scale of the severity or intensity of the adverse event The grading scale of the severity or intensity of the adverse event Severity Grade 1;Grade 2;Grade 3;Grade 4;Grade 5 Mild: asymptomatic or mild symtoms, clinical or diagnostic observations only, intervention not indicated.;Moderate: minimal, local or noninvasive intervention indicated, limiting age-appropriate Activities of Daily Living.;Severe or medically significant but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated, disabling, limiting self care Activities of Daily Living;Life-threatening consequences: urgent intervention indicated;Death related to adverse event 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 v4.0 (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) v4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html) Adult;Pediatric Supplemental 4.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

2201188
C08047 Medication anti-Parkinsonian reduced after surgery percent value MedAntiPrknsnRedPstSurgPrctVal Percent anti-Parkinsonism medication(s) were reduced Percent anti-Parkinsonism medication(s) were reduced Yes percent reduction Numeric Values

Only answered if Yes is selected for the previous question

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

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C18682 Functional neurosurgery target planning method other text FuncNeurosurgTrgtPlnngMethdOTH 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, 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 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

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C08025 L-Dopa pre-operative stim-off time LDOPAPreOpStmoffTime The pre-operative stimulation end (or off) time of the L-Dopa challenge response The pre-operative stimulation end (or off) time of the L-Dopa challenge response L-DOPA challenge responses Stim off time Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

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C08058 L-Dopa post-operative stim - off time LDOPAPstOpStimoffTime Post-operative stimulation end (or off) time of the L-Dopa challenge response Post-operative stimulation end (or off) time of the L-Dopa challenge response L DOPA challenge responses Stim off time Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C18762 Surgical complications post-operative mechanical malfunction other text SurgComplicPstOpMechMalfOTH The free-text field related to 'Surgical complications post-operative mechanical malfunction type' specifying other text. Type of post-operative mechanical malfunction experienced by the participant/subject The free-text field related to 'Surgical complications post-operative mechanical malfunction type' specifying other text. Type of post-operative mechanical malfunction experienced by the participant/subject Other, specify Alphanumeric

Choose only one. If there are multiple complications, refer to the General Adverse Events form for reporting instructions. 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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08069 Aborted procedures indicator AbrtProcInd Indicator of whether the procedure was aborted Indicator of whether the procedure was aborted Aborted Procedures Yes;No;Unknown Yes;No;Unknown Alphanumeric

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

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 Unilateral Left Right Left;Right Left;Right Alphanumeric

Only answer if 'Unilateral' is answered for 'Procedure'

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

Single Pre-Defined Value Selected

C08048 Medication anti-Parkinsonian added after surgery indicator MedAntiPrknsnAddPstSurgInd Indicator of whether anti-Parkinsonism medication(s) were added following optimization after surgery Indicator of whether anti-Parkinsonism medication(s) were added following optimization after surgery Following optimization were anti Parkinsonism medications added? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose only one.

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C18683 Functional neurosurgery other text FuncNeurosurgOTH The free-text field related to 'Functional neurosurgery type' specifying other text. Type of functional neurosurgical intervention The free-text field related to 'Functional neurosurgery type' specifying other text. Type of functional neurosurgical intervention Other, specify Alphanumeric

Choose one

No references available Adult Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

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C08026 Functional neurosurgery target anatomic site FuncNeurosurgTrgtAntmicSte 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 Intra Operative Information Target Subthalamic Nucleus (STN);Globus pallidus, pars interna (GPi);PPN Pedunculoponitine nucleus (PPN);Other, specify Subthalamic Nucleus (STN);Globus pallidus, pars interna (GPi);PPN Pedunculoponitine nucleus (PPN);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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08059 Surgery hardware replacement type SurgHrdwreReplcmntTyp Type of surgical hardware in need of replacement Type of surgical hardware in need of replacement Hardware Replacements Lead;IPG;Extender;N/A Lead;IPG;Extender;N/A Alphanumeric

If N/A is answered, skip to Q#7 (Was lead repositioned in patient?)

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C18763 Surgical complications post-operative other text SurgComplicPstOpOTH The free-text field related to 'Surgical complications post-operative type' specifying other text. Type of post-operative surgical complications experienced by the participant/subject The free-text field related to 'Surgical complications post-operative type' specifying other text. Type of post-operative surgical complications experienced by the participant/subject Other, specify Alphanumeric

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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08038 Surgery intra-operative target verification source SurgIntraOpTrgtVerifSrc 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 Image guidance platform;Software;Fluoroscopy;Microstimulation;Macrostimulation;X-ray;Microelectrode recording;Single electrode recording;Multiple-electrode recording (BEN-GUN) Image guidance platform;Software;Fluoroscopy;Microstimulation;Macrostimulation;X-ray;Microelectrode recording;Single electrode recording;Multiple-electrode recording (BEN-GUN) Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08070 Aborted procedures number AbrtProcNum Number of aborted procedures Number of aborted procedures If yes Number of aborted procedures Numeric Values

Only answer if 'Yes' is answered for 'Aborted procedures'. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C05106 Surgical or 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 (http://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;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

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C08049 Stimulation brain parameters monopolar range StimBrainParamMonoplrRng The monopolar stimulation parameters used on the participant/subject for surgery. In monopolar surgery/stimulation, the active electrode is in the surgical site and return electrode is attached somewhere else on the patient The monopolar stimulation parameters used on the participant/subject for surgery. In monopolar surgery/stimulation, the active electrode is in the surgical site and return electrode is attached somewhere else on the patient After optimization what were the stimulation parameters? Monopolar Alphanumeric

Using free text, give the monopolar stimulation parameters

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C18733 Lead implanted pulse generator model other text LeadIPGMdlOTH The free-text field related to 'Lead implanted pulse generator model type' specifying other text. Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery The free-text field related to 'Lead implanted pulse generator model type' specifying other text. Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery Other, specify Alphanumeric

Using the options listed, or free text, please specify the type of lead electrodes or implanted pulse generators used on the participant/subject for surgery

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08027 Functional neurosurgery type FuncNeurosurgTyp Type of functional neurosurgical intervention Type of functional neurosurgical intervention Procedure Unilateral;Bilateral;Other, specify Unilateral;Bilateral;Other, specify Alphanumeric

Choose one

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08060 Leads replaced number LeadReplacNum Number of leads replaced Number of leads replaced Lead number replaced Numeric Values

Only answer if 'Lead' is answered for 'Hardware replacements'

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08039 Electrode brain count ElectrdBrainCt Count of electrodes introduced in the brain Count of electrodes introduced in the brain Number of electrodes Numeric Values

Only answer if 'Multiple-electrode recording (BEN-GUN)' is answered for 'Intra-operative target verification'

No references available Adult;Pediatric Supplemental 4.00 2017-04-12 00:00:00.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

0 99
C08071 Aborted procedures reason AbrtProcRsn Reason for aborted procedures Reason for aborted procedures Reason aborted Infarct;Seizure;Cardiovascular (e.g., arrhythmia, heart attack, etc.);Change of mental status;Other, specify Infarct;Seizure;Cardiovascular (e.g., arrhythmia, heart attack, etc.);Change of mental status;Other, specify Alphanumeric

Only answer if 'Yes' is answered for 'Aborted procedures'. '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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

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;Pediatric Exploratory 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C08050 Stimulation brain parameters bipolar range StimBrainParamBiplrRng The bipolar stimulation parameters used on the participant/subject for surgery. Bipolar, twisted-pair electrodes are the most commonly used stimulating electrode. Benefits include limited stimulus artifacts. The bipolar stimulation parameters used on the participant/subject for surgery. Bipolar, twisted-pair electrodes are the most commonly used stimulating electrode. Benefits include limited stimulus artifacts. After optimization what were the stimulation parameters? Bipolar Alphanumeric

Using free text, give the bipolar stimulation parameters

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C18734 Lead repositioned other text LeadRepositOTH The free-text field related to 'Lead repositioned reason' specifying other text. Reason the lead was repositioned in the participant/subject The free-text field related to 'Lead repositioned reason' specifying other text. Reason the lead was repositioned in the participant/subject Other, specify Alphanumeric

Choose only one.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08029 Functional neurosurgery bilateral procedure type FuncNeurosurgBilatProcTyp Type of surgical intervention targeting both hemispheres of the brain. Type of surgical intervention targeting both hemispheres of the brain. Bilateral Simultaneous Staged Simultaneous;Staged Simultaneous;Staged Alphanumeric

Only answer if 'Bilateral' is answered for 'Procedure'

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08061 Implanted pulse generator replaced number IPGReplacNum Number of implanted pulse generators (IPGs) replaced Number of implanted pulse generators (IPGs) replaced IPG number replaced Numeric Values

Only answer if 'IPG' is answered for 'Hardware replacements'

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08040 Microelectrode passes number MicrelectrdPssNum Number of times the microelectrode is passed through the brain Number of times the microelectrode is passed through the brain Number of passes Numeric Values

Only answer if 'Microelectrode recording' is answered for 'Intra-operative target verification'

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08072 Surgical complication intracranial anatomic site SurgComplicIntracranAntmicSte Anatomic site of the surgical complication, if intracranial Anatomic site of the surgical complication, if intracranial Location of complication if intracranial Alphanumeric

Only answer if surgical complication is intracranial, otherwise leave blank. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C08018 Surgery age value SurgAgeVal Age of the participant/subject at the time of the selected surgical procedure Age of the participant/subject at the time of the selected surgical procedure Age at Time of Surgery Numeric Values

This element is not considered Core. Please refer to the Date of Birth element on the General Demographics form to derive age. If age is necessary to capture on this form, it may be added.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

0 99
C08051 Stimulation parameters 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C18750 Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered other text RFQSignfcntInjSxAnesthAdmOTH The free-text field related to 'Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type' specifying other text. Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). The free-text field related to 'Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type' specifying other text. Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Other, specify Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08030 Anterior commissure posterior commissure target coordinate value ACPCTrgtCoordVal Stereotactic coordinates with respect to anterior and posterior commissure (brain nuclei) Stereotactic coordinates with respect to anterior and posterior commissure (brain nuclei) AC PC target coordinates Alphanumeric

Specify left and right coordinates if procedure is unilateral

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C08062 Extenders replaced number ExtndrReplacNum Number of extenders replaced Number of extenders replaced Extender number replaced Numeric Values

Only answer if 'Extender' is answered for 'Hardware replacements'

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08073 Adverse event relatedness source AdvrsEvntRelatSrc What the adverse event or complication was likely related to or caused by What the adverse event or complication was likely related to or caused by Complication related to Surgery;Device;Other, specify Surgery;Device;Other, specify Alphanumeric

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08019 Disease duration DiseasDurat Duration of disease at time of surgery Duration of disease at time of surgery Disease Duration at Time of Surgery Numeric Values

This value should be captured in months and/or years.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08052 Stimulation brain parameters amplitude range StimBrainParamAmpRng Amplitude of electric pulses (stimulation) on brain hemisphere Amplitude of electric pulses (stimulation) on brain hemisphere Amplitude Range: Volts Numeric Values

This value should be answered in Volts. Answer for both left brain and right brain.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

Volt
C18755 Stereotactic surgery frame other text StereostatSurgFrmOTH 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

CRW (manufactured by Radionics) and Leksell (manufactured by Elekta) are the two most common frame types.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

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;Indirect;Atlas;Planning Platform;Imaging;Ventriculography;Other, specify Direct;Indirect;Atlas;Planning Platform;Imaging;Ventriculography;Other, 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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08063 Lead repositioned indicator LeadRepositInd Indicator of whether a lead was repositioned in the participant/subject Indicator of whether a lead was repositioned in the participant/subject Was lead repositioned in patient Yes;No;Unknown Yes;No;Unknown Alphanumeric

If N/A is answered, skip to Q#8 (Surgical complications)

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08042 Surgery externalization use indicator SurgExtrnlUseInd A procedure of exposing the implanted electrodes out of the brain for stimulation purposes A procedure of exposing the implanted electrodes out of the brain for stimulation purposes Use of Externalization Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08074 Adverse event relatedness source device type AdvrsEvntRelatSrcDevTyp If the adverse event or complication was likely related to or caused by a device, the type of device involved If the adverse event or complication was likely related to or caused by a device, the type of device involved Complication related to Device Electrode;IPG Electrode;IPG Alphanumeric

Answered only if Device is answered for previous question. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08020 Surgery reason indication type SurgRsnIndTyp Reason participant/subject is in need of surgery Reason participant/subject is in need of surgery Indication(s) for Surgery Tremors;Dyskinesias;Motor fluctuations;Drug/medication side effects;Trauma;Tracheostomy;Cardiomyopathy/Arrhythmia/Cardiac Device Implantation;Other, specify Tremors;Dyskinesias;Motor fluctuations;Drug/medication side effects;Trauma;Tracheostomy;Cardiomyopathy/Arrhythmia/Cardiac Device Implantation;Other, specify Alphanumeric

Select only one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

CSV