Deep Brain Stimulation and Parkinson's Disease

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
Brief Summary

- 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.

Overall Status Completed
Start Date September 1, 2014
Completion Date December 2017
Primary Completion Date December 2017
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) 1 month,
Secondary Outcome
Measure Time Frame
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) 1 month
Study of QUIP score (QUIP scale) 3 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation 1 month
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation 1 month
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation 1 month
Study of delayed discounting task (DDT) score 3 months
Enrollment 15
Condition
Intervention

Intervention Type: Device

Intervention Name: NIRS EEG HR recording

Description: NIRS EEG HR recording

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michel LEFRANC, MD Principal Investigator CHU Amiens
Location
Facility: CHU Amiens
Location Countries

France

Verification Date

August 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: parkinson's patient stimulated at STN level

Type: Experimental

Description: 15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording

Label: non STN

Type: Experimental

Description: 5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording

Label: control

Type: Experimental

Description: 20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording

Acronym SCP TCI NIRS
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov