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

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ClinicalTrials.gov Identifier: NCT03714854
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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
Parkinson Disease Device: transcranial magnetic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 5, 2018
Estimated Primary Completion Date : December 4, 2023
Estimated Study Completion Date : December 4, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. Cortico-subcortical connectivity [ Time Frame: 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 [ 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714854


Contacts
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Contact: FRAIX VALERIE 0476765791 VFraix@chu-grenoble.fr

Locations
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France
CHU de GRENOBLE ALPES Recruiting
Grenoble, France, 38043
Contact: Valérie FRAIX    0476765771    VFraix@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03714854    
Other Study ID Numbers: 2017-A03016-47
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases