Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients

NCT ID: NCT03714854

Last Updated: 2023-01-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2021-02-12

Brief Summary

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Akinesia is one of the most prominent symptom in Parkinson's Disease (PD) patients. It typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. This study aims at exploring the influence of Deep Brain Stimulation (DBS) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. They will be evaluated using behavioral and motor tasks together with Transcranial Magnetic Stimulation (TMS) and electrophysiology (EMG and EEG).

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep brain stimulation ON

Patients will undergo every experimental tasks with their DBS stimulator in ON and OFF positions. Order of ON/OFF conditions will be counterbalanced between patients.

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

TMS will be delivered on the sensory-motor system and the inhibitory motor control network while patients are performing behavioral and motor tasks. Brain and muscle activity will be recorded concurrently using EEG and EMG respectively.

Deep brain stimulation OFF

Patients will undergo every experimental tasks with their DBS stimulator in ON and OFF positions. Order of ON/OFF conditions will be counterbalanced between patients.

Group Type PLACEBO_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

TMS will be delivered on the sensory-motor system and the inhibitory motor control network while patients are performing behavioral and motor tasks. Brain and muscle activity will be recorded concurrently using EEG and EMG respectively.

Interventions

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transcranial magnetic stimulation

TMS will be delivered on the sensory-motor system and the inhibitory motor control network while patients are performing behavioral and motor tasks. Brain and muscle activity will be recorded concurrently using EEG and EMG respectively.

Intervention Type DEVICE

Other Intervention Names

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electroencephalography behavioral tasks electromyography

Eligibility Criteria

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Inclusion Criteria

* PD patients that are monitored for the tuning of their DBS stimulator by Grenoble's Hospital.
* PD patients that are hospitalized for the tuning routine 12 months after the surgical implantation.
* Good tolerance following temporary stops of the DBS stimulator
* Affiliated to a social security system
* Mental abilities sufficient for performing the behavioral tasks (MMSE score \>= 24, tested less than 6 months ago)

Exclusion Criteria

* Patients that are concerned by articles L1121-5, L1121-6, L1121-7 and L1121-8 of French Code de la Santé Publique,
* History of psychiatric or neurological illness other than PD
* Patients that are currently excluded from an other clinical trial
* Contraindications for TMS practice
* Inability to stay seated without pain for two hours
* Pregnancy
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de GRENOBLE ALPES

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03016-47

Identifier Type: -

Identifier Source: org_study_id

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