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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT03714854
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial magnetic stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
Actual Study Start Date :
Dec 5, 2018
Anticipated Primary Completion Date :
Dec 4, 2023
Anticipated Study Completion Date :
Dec 4, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. Cortico-subcortical connectivity [20 minutes]

      Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de GRENOBLE ALPES Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT03714854
    Other Study ID Numbers:
    • 2017-A03016-47
    First Posted:
    Oct 22, 2018
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Nov 23, 2021