Study of Motor Inhibition in Parkinson's Disease and Focal Hand Dystonia
PD-INHIB
1 other identifier
interventional
200
1 country
1
Brief Summary
The current research protocol aims at studying preparatory inhibition in two populations of patients suffering from movement disorders. First, in PART 1, we will work with Parkinson's disease (PD) patients to investigate the contribution of the basal ganglia in preparatory inhibition (Project 1 \[P1\] and Project 2 \[P2\]). Then, in PART 2, we will consider patients with focal hand dystonia (FHD), to test the hypothesis that altered muscle selectivity in this pathological condition is, at least in part, due to a lack of preparatory inhibition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jul 2018
Longer than P75 for not_applicable parkinson-disease
1 active site
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
Study Start
First participant enrolled
July 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2023
CompletedJanuary 26, 2022
January 1, 2022
4.7 years
July 23, 2019
January 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
TMS measures of preparatory Inhibition
TMS is applied while participants are performing the task, either at rest (baseline) or when they are preparing their response (delay). Preparatory Inhibition is assessed by expressing MEP amplitudes obtained at TMS-delay relatively to those obtained at TMS-baseline. In the present study, Preparatory Inhibition is assessed on two consecutive days in PD patients (ON and OFF dopamine replacement therapy in P1; ON and OFF DBS in P2; randomized order) and healthy control subjects.
Every participant comes to the laboratory on two consecutive days. All data is acquired on those two days and there are no follow-up measurements. Data acquisition is expected to take up to 6 months per arm.
Reaction times and movement times during the task
The choice RT task allows to measure the reaction and movement times (in ms) for each index finger (left and right), in both PD patients and control subjects.
Every participant comes to the laboratory on two consecutive days. All data is acquired on those two days and there are no follow-up measurements. Data acquisition is expected to take up to 6 months per arm.
Study Arms (3)
Parkinson's disease (PD) patients Group 1
EXPERIMENTALPD patients treated by Dopamine replacement therapy, recruited through Movement Disorders consultations at the Saint-Luc University Hospital, mainly of Prof. Jeanjean, Prof. Ivanoiu, Dr. Wilhelm
Parkinson's disease (PD) patients Group 2
EXPERIMENTALPD patients treated by Deep Brain Stimulation, recruited through Movement Disorders consultations at the Saint-Luc University Hospital, mainly of Prof. Jeanjean, Prof. Ivanoiu, Dr. Wilhelm
Healthy individuals
ACTIVE COMPARATORHealthy participants, aged between 18 and 85, will be recruited as control subjects by means of ads posting.
Interventions
Participants will be seated comfortably in front of a cathode ray tube screen, at a distance of 50-70 cm. The refresh rate of the monitor will be kept above 75 Hz to avoid visual fatigue. Participants will be asked to perform an instructed-delay choice reaction-time task in which they will have to choose between a left and right finger response. In this task, we measure the reaction-times and movement times.
While being comfortably seated in a chair and performing the pre-mentioned task, the participants will undergo single-pulse TMS over both primary motor cortices (M1). In order to guarantee the position of the stimulation coils throughout the testing, participants are asked to wear an EEG cap which will be used to mark various scalp locations. Bipolar surface electrodes, linked to an electromyography (EMG) system, will be placed over one or more muscles of each hand in order to measure the amplitude of motor evoked potentials at various stages of the task. Prior to the placement of each adhesive surface electrode, the skin will be gently swabbed with an alcohol solution.
Montreal Cognitive Assessment (MoCA), Beck Depression Inventory (BDI) II, Scale on impulsive behaviour (UPPS).
Specific Parkinson Questionnaire on Clinical motor status
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic PD (according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria) (for PD participants)
- Good response to levodopa (improvement on the UPDRS-III scale) (for PD participants)
- Hoehn and Yahr stage: \< or = 3 (for PD participants)
- Absence of severe tremor (for PD participants)
- Absence of dyskinesia (for PD participants)
- Between 18 and 85 years old (for all participants)
- Normal or corrected-to-normal vision (for all participants)
You may not qualify if:
- Severe cognitive impairment (Score of \<21/30 with the Montreal Cognitive Assessment (MoCA))
- MRI-incompatible metal device in the body
- History of major psychiatric or neurological disorder (other than PD for the patient group)
- Personal or family history of epilepsy
- History of substance use disorder (except nicotine)
- Untreated or unstable medical conditions that could interfere with cognitive functioning
- Undergoing any drug treatment that can significantly alter task performance or neural activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian IVANOIU, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- STUDY DIRECTOR
Julie DUQUE, PhD
Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
January 26, 2022
Study Start
July 31, 2018
Primary Completion
April 23, 2023
Study Completion
April 23, 2023
Last Updated
January 26, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share