Loss of Depotentiation in Focal Dystonia

NCT03206112 | Terminated

• 2 other identifiers: 17012317-N-0123
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Background Focal dystonia is a brain disorder. It affects a muscle or muscles in a specific part of the body. Researchers think it may be related to excessive training or practice. They want to know more about how much training might trigger focal dystonia. Objectives: To study why people develop focal dystonia. To study how brain plasticity changes with focal dystonia. Eligibility: People at least 18 years of age with focal dystonia. Healthy volunteers the same age are also needed. Design: Participants will be screened with a physical exam and questions. They may have blood and urine tests. Participants will have up to 3 testing visits. Participants will have small electrodes stuck on the skin on the hands or arms. Muscle activity will be recorded. Participants will have transcranial magnetic stimulation (TMS). A wire coil will be placed onto the scalp. A brief electrical current will pass through the coil. The current will create a magnetic field that affects brain activity. Participants may be asked to tense certain muscles or do simple actions during TMS. A nerve at the wrist will get weak electrical stimulation. The stimulation may be paired with TMS for very short times. Participants will receive repeated magnetic pulses. Participants will receive a total of 150 pulses during a 10-second period. An entire testing visit will last about 3 hours. ...

Conditions

Focal Dystonia; Healthy Volunteers

Keywords

Focal Dystonia; Healthy Volunteers; Paired Associative Stimulation (PAS)

Outcome Measures

Primary Outcomes (1)

• MEP amplitude immediately after the PAS25-cTBS150 (depotentiation) protocol

  compare MEP amplitude in patients with that in healthy volunteers to identify whether depotentiation is weaker in focal dystonia

  throughout

Secondary Outcomes (1)

• MEP amplitudes

  throughout

Study Arms (2)

Focal Dystonia

Subjects diagnosed with Focal Dystonia

Other: PAS25; Other: PAS10; Other: PAS25-cTBS150

Healthy Volunteers

Healthy Volunteers

Other: PAS25; Other: PAS10; Other: PAS25-cTBS150

Interventions

PAS25 OTHER

We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles.

Focal Dystonia; Healthy Volunteers

PAS10 OTHER

We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles. TBS is a special form of

Focal Dystonia; Healthy Volunteers

PAS25-cTBS150 OTHER

We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles.

Focal Dystonia; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects (patients and healthy volunteers) are recruited through the NIH Patient Recruitment and Public Liaison Office and from individuals who have participated in prior studies and are interested in being contacted for additional studies. Additionally, individuals who have contacted NIH to volunteer for research studies will be considered for recruitment.

You may qualify if:

• At least 18 years old.\*
• Able to give informed consent.
• Able to comply with all study procedures.
• Abstain from alcohol for at least 48 hours prior to each study visit and caffeine on the day of the visit.
• Have no neurological or psychiatric disorders established by history and physical/neurological examination.
• = A maximum of 10 subjects who are over the age of 70 will be screened for plasticity. If none of these subjects have plasticity, we will not accrue any more subjects over the age of 70.
• At least 18-years old.\*
• Able to give informed consent.
• Able to comply with all study procedures.
• Abstain from alcohol for at least 48 hours prior to each visit of the study and caffeine on the day of the visit.
• Have an established diagnosis of focal dystonia.
• No botulinum toxin injections at least in the past 3 months.
• = A maximum of 10 subjects who are over the age of 70 will be screened for plasticity. If none of these subjects have plasticity, we will not accrue any more subjects over the age of 70.

You may not qualify if:

• Self-reported consumption of \> 14 alcoholic drinks/week for a man and \> 7 alcoholic drinks/week for a woman.
• Focal dystonia patients: presence of abnormal findings on neurological examination except for the diagnosis of focal dystonia. Healthy volunteers: no abnormal findings on neurological examination.
• History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
• Have a Baclofen pump, or have neurostimulators for pain.
• Pregnant or breastfeeding women.
• Current episode of major depression or any major psychiatric illness.
• Presence of any metal in the eye or skull area such as a brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
• Presence of pacemaker, intracardiac lines, implanted pumps or stimulators.
• Known hearing loss.
• Cognitive impairment.
• NIH staff from HMCS.
• Healthy Volunteers:
• Taking medications that act directly on the central nervous system such as anti- epileptics, anti-histamines, anti-parkinsonian medication, medication for insomnia, anti-depressants, anti-anxiety medication.
• Focal Dystonia Patients:
• Taking medications that act directly on the central nervous system such as anti- epileptics, anti-parkinsonian medication, medication for insomnia.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: September 20, 2017
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-04

Locations

US (1)