Status:
COMPLETED
The Effects of Repetitive Paired Associative Stimulation in Dystonia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Dystonia
Eligibility:
All Genders
18-100 years
Brief Summary
Background: \- People with dystonia have serious muscle contractions that cause abnormal movements or postures. This significantly affects their daily lives. The common type is called organic. The ot...
Detailed Description
Objective: To investigate the effects of pairing brain and peripheral nerve stimulation in organic and psychogenic dystonia to see if this technique can differentiate them. Study Population: We int...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For the organic dystonia group: Primary focal dystonia diagnosed or confirmed by a movement disorders neurologist, confirmed at the initial visit by a study investigator.
- For the psychogenic dystonia group: Clinically established psychogenic dystonia or probable psychogenic dystonia, according to the Fahn and Williams criteria confirmed by a movement disorders neurologist.
- For the healthy volunteers group: Age-matched healthy volunteers three will be age matched to pyschogenic dystonia group, and three will be age matched to organic dystonia group.
- Adult patients (at least18 years old).
- Right handed.
- Ability to provide own consent
- EXCLUSION CRITERIA:
- Dystonia affecting the right APB and/or FDI, or inability of the subject to perform full range-of-motion exercises with the right FDI and/or APB.
- Medical condition impairing the subject's ability to comply with the study protocol as judged by study investigator, such as but not limited to seizures, brain tumor, stroke, bipolar disorder, depression, hearing problem, uncontrolled systemic hypertension with values above 170/100, heart disease or lung disease, active respiratory disease needing intervention; and pain preventing lying still for up to 40 minutes.
- Current or prior use of botulinum toxin within 3 months prior to TMS intervention.
- Current or prior use of CNS drugs (including antidepressants, anxiolytics, anticonvulsants, antipsychotics, anti-parkinsonian drugs, hypnotics, stimulants, and/or antihistamines) within 1 week prior to TMS intervention.
- Active drug or alcohol intake more than 7 alcohol drinks/week for women and more than 14 alcoholic drinks/week for men.
- Current pregnancy and lactating women. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at least 24 hours prior to TMS procedures.
- Presence of implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, history of shrapnel injury or any other condition/device that may be contraindicated
- Inability or unwillingness of subject to provide written informed consent.
Exclusion
Key Trial Info
Start Date :
June 18 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01888926
Start Date
June 18 2013
End Date
August 2 2016
Last Update
February 14 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892