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Clinical Trials/NCT02795663
NCT02795663CompletedPhase 1

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country15 target enrollmentStarted: September 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

parkinson's patient stimulated at STN level

Experimental

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

Intervention: NIRS EEG HR recording (Device)

non STN

Experimental

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

Intervention: NIRS EEG HR recording (Device)

control

Experimental

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

Intervention: NIRS EEG HR recording (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)(1 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 QUIP score (QUIP scale)(3 month)
  • Study of delayed discounting task (DDT) score(3 months)
  • Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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