Pathophysiology of Focal Hand Dystonia (NCT03223623) | Clinical Trial Compass
CompletedNot Applicable
Pathophysiology of Focal Hand Dystonia
United States32 participantsStarted 2017-12-12
Plain-language summary
Background:
Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD.
Objectives:
To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD.
Eligibility:
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age.
Design:
Participants will be screened with physical exam, neurological exam, and medical history. They may give a urine sample and will answer questions.
Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days.
Participants will have MRI scans. They will lie on a table that slides in and out of a scanner that takes pictures of their brain. They will do small tasks or be asked to imagine things during the scanning.
Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with breaks. A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse. This affects brain activity. Participants may do small tasks during TMS.
Participants will have the electrical activity of their muscles measured during TMS sessions. Small sticky pads will be attached to their hands and arms.
Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers. They will also be asked to feel small plastic domes with ridges, that may cause discomfort.
Who can participate
Age range
18 Years – 70 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:
Healthy research volunteers and adult patients with FHD will be eligible for the study.
* Age between 18 - 70 years.
* Able to give informed consent.
* Able to comply with all study procedures.
* Subjects must be willing to abstain from alcohol for at least 48 hours prior to the study.
* Adult patients with an established diagnosis of FHD.
* Healthy volunteers will be healthy subjects without neurological or psychiatric disorders established by history and physical/neurological examination.
* Patients receiving botulinum toxin injections will be evaluated after 3 months since their last injection.
* All participants must be able to obtain an MRI (No contraindications per MRI safety checklist) which will be part of the initial evaluation.
EXCLUSION CRITERIA:
* Self-reported consumption of \>14 alcoholic drinks/week for a man and \>7 alcoholic drinks/week for a woman.
* Patients on daily chronic opioid or benzodiazepine use.
* Patients treated with anticholinergics, who are not willing and/or unable to withhold taking them for 1 week prior and for the duration of the study participation.
* Patients taking opioids and/or benzodiazepines on an as needed basis, who are not willing and/or unable to withhold taking them for 1 week or time interval equivalent to 5 half-lives (whichever is shorter) prior to study participation and for the days during study participation.
* Abnormal findings on neurological examination including cognitive impairment, except di…
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
explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions.
Timeframe: throughout
Trial details
NCT IDNCT03223623
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)