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 Additional Notes (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
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

C08053 Stimulation brain parameters frequency range StimBrainParamFreqRng Frequency (Hz) of electric pulses (stimulation) on brain hemisphere Frequency (Hz) of electric pulses (stimulation) on brain hemisphere Frequency Range: Hz Numeric Values

This value should be answered in Hertz (Hz) 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

Hertz
C18757 Surgery lead secure method other text SurgLeadSecurMethdOTH 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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08032 Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type RFQSignfcntInjSxAnesthAdmType Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Type of Anesthesia General;Local;Other, specify;Spinal block General;Local;Other, specify;Spinal block 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

C08064 Lead repositioned reason LeadRepositRsn Reason the lead was repositioned in the participant/subject Reason the lead was repositioned in the participant/subject If yes please select reason lead repositioned Poor positioning;Mechanical breakdown;Infection;Other, specify Poor positioning;Mechanical breakdown;Infection;Other, specify 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

C08043 Lead implanted pulse generator model type LeadIPGMdlTyp Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery Lead and IPG Modes Used Lead 3387;Lead 3389;IPG Soletra;IPG Kinetra;IPG Activa PC;IPG Activa RC;Medtronic;Other, specify Lead 3387;Lead 3389;IPG Soletra;IPG Kinetra;IPG Activa PC;IPG Activa RC;Medtronic;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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08075 Adverse event expected status AdvrsEvntExpecStatus Whether the adverse event or complication was expected or unexpected Whether the adverse event or complication was expected or unexpected Was complication expected? Expected;Unexpected Expected;Unexpected 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

C08021 Surgery indication drug or medication side effects type SurgIndicDrgMedSdEffctTyp Type of drug or medication side effects experienced by the participant/subject Type of drug or medication side effects experienced by the participant/subject Drug Medication Side Effects Insomnolence;Behavioral effects;Nausea/vomiting Insomnolence;Behavioral effects;Nausea/vomiting Alphanumeric

Only answer if "Drug/Medication side effects" is answered for 'Indication(s) for surgery'

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

C08054 Stimulation brain parameters pulse width range StimBrainParamPlsWdthRng Width of electric pulses (stimulation) on brain hemisphere Width of electric pulses (stimulation) on brain hemisphere Pulse Width Range: microsec Numeric Values

This value should be answered in microseconds (?sec) 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

microsecond
C18758 Surgery post-operative target verification method other text SurgPstOpTrgtVerifMethdOTH 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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

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-Parinsonian Medication(s) during Procedure 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

C08065 Surgical complications category SurgComplicCat Category of the surgical complication experienced by the participant/subject Category of the surgical complication experienced by the participant/subject Surgical Complications Intra-Operative;Post-Operative;N/A Intra-Operative;Post-Operative;N/A Alphanumeric

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.

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

C08044 Operating room total time OpRmTtlTm Participant's/subject's total time in the operating room Participant's/subject's total time in the operating room Total Time in the Operating Room Numeric Values

This value should be collected in hours and minutes.

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

C18662 Aborted procedures other text AbrtProcOTH The free-text field related to 'Aborted procedures reason' specifying other text. Reason for aborted procedures The free-text field related to 'Aborted procedures reason' specifying other text. Reason for aborted procedures 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 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08022 Imaging magnetic resonance imaging findings result indicator ImgMRIFndngResltInd Results from MRI studies Results from MRI studies indicator MRI Findings Abnormal;Normal Abnormal;Normal 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

C08055 Stimulation brain mean value StimBrainMeanVal Mean (average) value of electric pulses (stimulation) on brain hemisphere Mean (average) value of electric pulses (stimulation) on brain hemisphere Mean Numeric Values

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

C18759 Surgery reason indication other text SurgRsnIndOTH The free-text field related to 'Surgery reason indication type' specifying other text. Reason participant/subject is in need of surgery The free-text field related to 'Surgery reason indication type' specifying other text. Reason participant/subject is in need of surgery Other, specify Alphanumeric

Select 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

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 Elevated;Flat Elevated;Flat 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

C08066 Surgical complications 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 Complication Intra Operative Hemorrhage;Infarct;Seizure;Cardiovascular (e.g., arrhythmia, heart attack, etc.);Change of mental status;Other, specify Hemorrhage;Infarct;Seizure;Cardiovascular (e.g., arrhythmia, heart attack, etc.);Change of mental status;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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08045 Surgery post-operative target verification method source SurgPstOpTrgtVerifMethdSrc 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 Post operative Target Verification 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;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

C18664 Adverse event relatedness other text AdvrsEvntRelatOTH The free-text field related to 'Adverse event relatedness source' specifying other text. What the adverse event or complication was likely related to or caused by The free-text field related to 'Adverse event relatedness source' specifying other text. What the adverse event or complication was likely related to or caused by 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 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C02302 Adverse event other action taken type AdvEvntOthrActionTakenTyp Type of action taken due to adverse event other than action taken with study intervention/ treatment Type of action taken due to adverse event other than action taken with study intervention/ treatment Other Action Taken None;Non-Study Treatment Required None;Non-Study Treatment Required 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;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

3141322
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;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C08056 Stimulation brain range value StimBrainRngVal Range of electric pulses used on brain hemisphere (Pulse amplitude, frequency and width.) Range of electric pulses used on brain hemisphere (Pulse amplitude, frequency and width.) Range Numeric Values

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

C18760 Surgery skull opening other text SurgSkulOpngOTH 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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08035 Stereotactic surgery frame type StereostatSurgFrmTyp Scaffold or support used for stereotactic surgery Scaffold or support used for stereotactic surgery Frame Type CRW;Leksell;Mini-Frame;Other, specify CRW;Leksell;Mini-Frame;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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08067 Surgical complications post-operative type SurgComplicPstOpTyp Type of post-operative surgical complications experienced by the participant/subject Type of post-operative surgical complications experienced by the participant/subject Complication Post Operative Hemorrhage;Infarct;Infection;Seizure;Mechanical malfunction;Other, specify Hemorrhage;Infarct;Infection;Seizure;Mechanical malfunction;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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08046 Medication anti-Parkinsonian reduced after surgery indicator MedAntiPrknsnRedPstSurgInd 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 weeks after surgery (fill in blank) were anti Parinsonism medications reduced? Yes, % reduction;No;N/A;Unknown Yes, % reduction;No;N/A;Unknown Alphanumeric

Choose ony 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

C18681 Functional neurosurgery target anatomic other text FuncNeurosurgTrgtOTH 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 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C02303 Adverse event outcome status AdvrsEvntOutcomStatus Final status of the participant/subject related to the adverse event Final status of the participant/subject related to the adverse event Outcome Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown Alphanumeric

Choose one outcome. The outcome of an AE may not be captured at the visit during which it was first reported, but must eventually be captured to provide a complete picture of the event. Entering the outcome of an AE may be deferred until the AE is resolved, or the participant/subject completes the study. For AEs that have not resolved at the time of a study visit, the outcome should be marked as "Not recovered/not resolved" on the AE case report form.

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

2746517
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

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

Free-Form Entry

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

Free-Form Entry

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
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

Free-Form Entry

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

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

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 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

CSV