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 range18 Years – 65 Years

SexALL

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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). …

What they're measuring

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)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-07-25