Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective o… (NCT02504905) | Clinical Trial Compass
CompletedEarly Phase 1
Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing
United States58 participantsStarted 2015-08-20
Plain-language summary
Background:
\- People with dystonia have muscle contractions they can t control. These cause slow, repeated motions or abnormal postures. People with dystonia have abnormalities in certain parts of the brain. Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia.
Objective:
\- To compare brain activity in people with dystonia to that in healthy people.
Eligibility:
* Right-handed people ages of 18-65 with cervical dystonia or writer s cramp.
* Healthy volunteers the same ages.
Design:
* Participants will be screened with a physical exam. They will answer questions about being right- or left-handed.
* At study visit 1, participants will:\<TAB\>
* Have a neurological exam.
* Answer questions about how their disease impacts their daily activities.
* Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a table that can slide \<TAB\>in and out of a metal cylinder. This is surrounded by a strong magnetic field.
* Do 2 simple computer tasks.
* At study visit 2:
* Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head. Two wire coils will be held on the scalp. A brief electrical current creates a magnetic pulse that affects brain activity. Muscles of the face, arm, or leg might twitch. Participants may have to tense certain muscles or do simple tasks during TMS. They may be asked to rate any discomfort caused by TMS.
* Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand.
Who can participate
Age range
18 Years – 65 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:
* Between the ages of 18 and 65 years
* Right-handed
* English speaking
* For patients only: confirmed diagnosis of cervical dystonia (PAR-CD) or writer s cramp (PAR-WC).
* For patients treated with anticholinergics and/or benzodiazepines, they must be willing and safely able to abstain from any of these medication for a period of at least 5 plasma half-lives of the individual drug prior to study participation (2 days for trihexyphenidyl which has a plasma half life around 4 hours; 12 days, for clonazepam which has a half-life of 18-50 hours).
* For HVs only: absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
* Ability to give informed consent
* Ability to comply with all study procedures, based on the judgment by the investigator(s).
EXCLUSION CRITERIA:
Any of the following will exclude patients from the study:
* Secondary forms of dystonia, including tardive dyskinesia.
* Dystonic tremor where the tremor is the sole or principal abnormality.
* Botulinum toxin treatment \< 3 months prior to visit.
Any of the following will exclude patients or healthy controls from the study:
* Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
* Self-reported consumption of 7 alcoholic drinks a week for women and \>14 alcoholic drinks a week for man.
* Abnormal findings on neurologic exam (other than dystonia in patient group).
…
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
MEP size at S50 with respect to time (before, and 15-20 min after PAS intervention)
Timeframe: throughout
Trial details
NCT IDNCT02504905
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)