Study of Motor Inhibition in Parkinson's Disease and Focal Hand Dystonia (NCT05209516) | Clinical Trial Compass
UnknownNot Applicable
Study of Motor Inhibition in Parkinson's Disease and Focal Hand Dystonia
Belgium200 participantsStarted 2018-07-31
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria (for all participants):
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TMS measures of preparatory Inhibition
Timeframe: 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.
2
Reaction times and movement times during the task
Timeframe: 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.
Trial details
NCT IDNCT05209516
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain