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Protocol Details

Loss of Depotentiation in Focal Dystonia

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0123

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Focal Dystonia;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: PAS25-cTBS150

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

Inclusion criteria for healthy controls:

-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.

Inclusion criteria for focal dystonia patients:

-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.

EXCLUSION CRITERIA:

-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.

NOTE: Patients taking anti-histamines, anti-depressants or anti-anxiety medications will not be excluded from the protocol. However, only patients who have mild symptoms and agree to temporarily stop the medications during the experiment will be included.

Patients with mild symptoms of depression will be confirmed using Hamilton Depression Rating Scale with total scores below 13. Patients with mild symptoms of anxiety will be confirmed using Hamilton Anxiety Rating Scale with total scores below 17. Patients will be required to stop their medication at least 5 half- lives of the drug, but no longer than 5 days (even if the half-life is longer than 24 hours) before each experimental session.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03206112

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