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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Parkinson Disease

Treatments: Device: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03714854

2017-A03016-47

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

Deep brain stimulation ON

Active Comparator group

Description:

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.

Treatment:

Device: transcranial magnetic stimulation

Deep brain stimulation OFF

Placebo Comparator group

Description:

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.

Treatment:

Device: transcranial magnetic stimulation