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Clinical Trials/NCT03714854
NCT03714854
Terminated
Not Applicable

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

University Hospital, Grenoble1 site in 1 country6 target enrollmentDecember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University Hospital, Grenoble
Enrollment
6
Locations
1
Primary Endpoint
Corticospinal excitability
Status
Terminated
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 5, 2018
End Date
February 12, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Cortical excitability(60 minutes)
  • Cortico-subcortical connectivity(20 minutes)
  • Correlation between behavioral and neural responses(60 minutes)

Study Sites (1)

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