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

Not Applicable

Terminated

• Conditions: Parkinson Disease

• Registration Number: NCT03714854
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-22
• Study Start: 2018-12-05
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Corticospinal excitability	60 minutes	Corticospinal excitability is measured trough the amplitudes of TMS-evoked motor potentials recorded on the EMG at rest, and during the behavioral and motor tasks, in the two experimental conditions (DBS stimulator ON and OFF).

Secondary Outcome Measures

Name	Time	Method
Cortical excitability	60 minutes	Cortical excitability is measured trough the amplitudes of TMS-evoked potentials recorded on the EEG at rest, in the two experimental conditions (DBS stimulator ON and OFF).
Cortico-subcortical connectivity	20 minutes	Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.
Correlation between behavioral and neural responses	60 minutes	Behavioral outcomes (such as reaction time, performance index, etc.) will be compared with neural correlates described in outcomes 1 and 2 and 3.

Trial Locations

Locations (1)

CHU de GRENOBLE ALPES; 🇫🇷 Grenoble, France