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

Parkinson Disease Clinical Trial

— PARKMOTEUR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03714854
• Other study ID #: 2017-A03016-47
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: February 12, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU de GRENOBLE ALPES	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	60 minutes
Secondary	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).	60 minutes
Secondary	Cortico-subcortical connectivity	Cortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.	20 minutes
Secondary	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.	60 minutes