NCT03714854

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

October 16, 2018

Last Update Submit

January 6, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cortical excitability

    60 minutes

  • Cortico-subcortical connectivity

    20 minutes

  • Correlation between behavioral and neural responses

    60 minutes

Study Arms (2)

Deep brain stimulation ON

ACTIVE COMPARATOR

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

Deep brain stimulation OFF

PLACEBO COMPARATOR

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

Interventions

transcranial magnetic stimulationDEVICE

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.

Also known as: electroencephalography, behavioral tasks, electromyography
Deep brain stimulation OFFDeep brain stimulation ON

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de GRENOBLE ALPES

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic StimulationElectroencephalographyElectromyography

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsDiagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMyography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 22, 2018

Study Start

December 5, 2018

Primary Completion

February 12, 2021

Study Completion

February 12, 2021

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

FR(1)