Transcranial Magnetic Stimulation for Focal Hand Dystonia

NCT01792336 | Terminated

• 2 other identifiers: 13007613-N-0076
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.
• Focal hand dystonia, also known as "writer's cramp" or "musician's cramp," is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia. Objectives: \- To better understand brain rhythms involved in focal hand dystonia. Eligibility:
• Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.
• Healthy right-handed volunteers between 18 and 60 years of age. Design:
• Participants will be screened with a physical exam and medical history.
• This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.
• Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held on their scalp. A brief electrical current will pass through the coil. It creates a magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and left sides of the head. This will help find the spot that activates the finger muscles, and see how much TMS is needed.
• In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated magnetic pulses delivered in short bursts. There will be four pulses in each burst. Participants will have multiple bursts during the test. This test will look at how the muscles of the hand and fingers respond to brain stimulation.
• Treatment for focal hand dystonia will not be provided as part of this study.

Conditions

Dystonia

Keywords

Repetitive TMS (rTMS); Transcranial Magnetic Stimulation (TMS); Motor Cortex; Focal Hand Dystonia; Facilitation

Outcome Measures

Primary Outcomes (1)

• Motor evoked potential following TMS conditioning versus the baseline MEP amplitude in dystonia patients and healthy subjects.

  6 months

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of focal hand dystonia (patients only).
• Between age 18 and 70 years.
• Able to give informed consent
• Right handed
• Agrees to not drink caffeine or alcohol for 48 hours before study session.
• No open scalp wounds or scalp infections.

You may not qualify if:

• Has used illegal drugs within the past 6 months based on history, including but not limited to marijuana, cocaine, methamphetamine, etc. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
• Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
• Abnormal findings on neurologic exam (other than dystonia in patient group)
• Has had a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.
• Has major depression or any major mental disorders (axis I disorders)
• Has a neurologic disorder other than dystonia
• Has had a head injury where there was a loss of consciousness for more than a few seconds.
• Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed.
• Has known hearing loss.
• Pregnancy
• Taking any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, and sympathomimetics.
• Has excessive daytime sleepiness as indicated by a score of 10 or higher on the Epworth Sleepiness Scale.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Brown P, Farmer SF, Halliday DM, Marsden J, Rosenberg JR. Coherent cortical and muscle discharge in cortical myoclonus. Brain. 1999 Mar;122 ( Pt 3):461-72. doi: 10.1093/brain/122.3.461.

  PMID: 10094255 BACKGROUND

• Cardin JA, Carlen M, Meletis K, Knoblich U, Zhang F, Deisseroth K, Tsai LH, Moore CI. Driving fast-spiking cells induces gamma rhythm and controls sensory responses. Nature. 2009 Jun 4;459(7247):663-7. doi: 10.1038/nature08002. Epub 2009 Apr 26.

  PMID: 19396156 BACKGROUND

• Crowell AL, Ryapolova-Webb ES, Ostrem JL, Galifianakis NB, Shimamoto S, Lim DA, Starr PA. Oscillations in sensorimotor cortex in movement disorders: an electrocorticography study. Brain. 2012 Feb;135(Pt 2):615-30. doi: 10.1093/brain/awr332. Epub 2012 Jan 16.

  PMID: 22252995 BACKGROUND

MeSH Terms

Conditions

Dystonia; Dystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: February 13, 2013
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-02-19

Locations

US (1)