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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03714854
Acronym
PARKMOTEUR
Enrollment
6
Registered
2018-10-22
Start date
2018-12-05
Completion date
2021-02-12
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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).

Interventions

DEVICEtranscranial 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.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corticospinal excitability60 minutesCorticospinal 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

MeasureTime frameDescription
Cortical excitability60 minutesCortical 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 connectivity20 minutesCortico-subcortical connectivity will be assessed on EEG signal using paired stimulation between TMS and DBS.
Correlation between behavioral and neural responses60 minutesBehavioral outcomes (such as reaction time, performance index, etc.) will be compared with neural correlates described in outcomes 1 and 2 and 3.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026