Deep Brain Stimulation and Parkinson's Disease

NCT ID: NCT02795663

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2017-12-31

Brief Summary

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* 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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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parkinson's patient stimulated at STN level

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

Group Type EXPERIMENTAL

NIRS EEG HR recording

Intervention Type DEVICE

NIRS EEG HR recording

non STN

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

Group Type EXPERIMENTAL

NIRS EEG HR recording

Intervention Type DEVICE

NIRS EEG HR recording

control

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

Group Type EXPERIMENTAL

NIRS EEG HR recording

Intervention Type DEVICE

NIRS EEG HR recording

Interventions

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NIRS EEG HR recording

NIRS EEG HR recording

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel LEFRANC, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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Mahmoudzadeh M, Wallois F, Tir M, Krystkowiak P, Lefranc M. Cortical hemodynamic mapping of subthalamic nucleus deep brain stimulation in Parkinsonian patients, using high-density functional near-infrared spectroscopy. PLoS One. 2021 Jan 25;16(1):e0245188. doi: 10.1371/journal.pone.0245188. eCollection 2021.

Reference Type RESULT
PMID: 33493171 (View on PubMed)

Other Identifiers

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PI2013_843_0016

Identifier Type: -

Identifier Source: org_study_id

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