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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de GRENOBLE ALPES

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Deep brain stimulation ON

Deep brain stimulation OFF

Arm 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.

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.

Outcomes

Primary Outcome Measures

Corticospinal excitability
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

Cortical excitability
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
Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.
Correlation between behavioral and neural responses
Behavioral outcomes (such as reaction time, performance index, etc.) will be compared with neural correlates described in outcomes 1 and 2 and 3.

Full Information

First Posted
October 16, 2018
Last Updated
January 6, 2023
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03714854
Brief Title
Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
Acronym
PARKMOTEUR
Official Title
Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties due to the loss of the engineer in charge of the TMS
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
February 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation ON
Arm Type
Active Comparator
Arm 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.
Arm Title
Deep brain stimulation OFF
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Other Intervention Name(s)
electroencephalography, behavioral tasks, electromyography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Corticospinal excitability
Description
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).
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Cortical excitability
Description
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).
Time Frame
60 minutes
Title
Cortico-subcortical connectivity
Description
Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.
Time Frame
20 minutes
Title
Correlation between behavioral and neural responses
Description
Behavioral outcomes (such as reaction time, performance index, etc.) will be compared with neural correlates described in outcomes 1 and 2 and 3.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de GRENOBLE ALPES
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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