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

January 6, 2023 updated by: University Hospital, Grenoble
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Other Names:
  • electroencephalography
  • behavioral tasks
  • electromyography
Placebo Comparator: 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.
Device: 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.
Other Names:
  • electroencephalography
  • behavioral tasks
  • electromyography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corticospinal excitability
Time Frame: 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).
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical excitability
Time Frame: 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).
60 minutes
Cortico-subcortical connectivity
Time Frame: 20 minutes
Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.
20 minutes
Correlation between behavioral and neural responses
Time Frame: 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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

February 12, 2021

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03016-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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