Deep Brain Stimulation and Parkinson's Disease (SCP TCI NIRS)
September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens
Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task
- Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
- Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
- Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amiens, France, 80054
- Chu Amiens
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients presenting Parkinson disease and treated by STN-DBS.
- For comparison patients: Patients treated by DBS in other target.
Exclusion Criteria:
- Patients who cannot be treated by DBS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: parkinson's patient stimulated at STN level
15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording
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NIRS EEG HR recording
|
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Experimental: non STN
5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording
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NIRS EEG HR recording
|
|
Experimental: control
20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording
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NIRS EEG HR recording
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Time Frame: 1 month,
|
under " on " and " off " stimulation during a motor task.
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1 month,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Time Frame: 1 month
|
under " on " and " off " stimulation during delay discounting task.
|
1 month
|
|
Study of QUIP score (QUIP scale)
Time Frame: 3 month
|
3 month
|
|
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Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation
Time Frame: 1 month
|
between patient with ICD and patient without ICD
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1 month
|
|
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
Time Frame: 1 month
|
1 month
|
|
|
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
Time Frame: 1 month
|
under " on " and " off " stimulation during a motor task and a delay discounting task (in order to obtain a qualitative comparison between GPi-DBS and STN-DBS.
|
1 month
|
|
Study of delayed discounting task (DDT) score
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michel LEFRANC, MD, Chu Amiens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
May 26, 2016
First Submitted That Met QC Criteria
June 9, 2016
First Posted (Estimated)
June 10, 2016
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 16, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2013_843_0016
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