Depotentiation in People With Focal Hand Dystonia

NCT02106936 | Terminated

• 2 other identifiers: 14007014-N-0070
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or postures. Musicians, writers, and athletes often get it. Researchers want to study how patients with this condition learn, a process of the brain that depends on a property called plasticity. Objective: \- To study brain plasticity in people with FHD. Eligibility:

• Right-handed adults 18 years and older with FHD.
• Healthy, right-handed adult volunteers. Design:
• Participants will be screened with medical history, physical exam, pregnancy test, and questionnaire about their right-handedness.
• Participants will have 2 study visits on 2 different days.
• Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation (TMS) pulses on the left side of the head. A brief electrical current passes through a wire coil on the scalp. They will hear a click and may feel a pulling on the skin or muscle twitches. They may have to keep their eyes open and remain alert, tense certain muscles, or perform simple finger movements.
• Forty more pulses, with 10 seconds between, will be given on the left side of the head. Some will be small, some big.
• Researchers will measure muscle response through small electrodes taped to the right hand.
• A cloth cap will be put on the participant s head. Researchers will write on tape on the cap.
• Participants will have the r-PAS. An electrical stimulator will be placed on the nerve at the right wrist. Repeated magnetic pulses will be delivered in trains or short bursts together with electrical stimulation of nerve. Participants will receive up to 840 pulses.
• Participants will be contacted after a few days for a follow-up check.

Conditions

Focal Dystonia; Healthy Volunteers

Keywords

Focal Hand Dystonia; Depotentiation; Transcranial Magnetic Stimulation (TMS); Rapid Paired Associative Stimulation; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Motor evoked potential amplitude

  Immediate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years or older
• Must be right-handed
• FHD includes only writer s cramp
• Must be able to provide consent
• No open scalp wounds or scalp infections.
• Agrees to not drink caffeine or alcohol for 48 hours before study session.

You may not qualify if:

• Has used illegal drugs within the past 6 months based on history. 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, head trauma, 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 metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye,
• Has known hearing loss.
• Pregnancy and lactation
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Prachaya Srivanitchapoom, MD: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Centonze D, Costa C, Rossi S, Prosperetti C, Pisani A, Usiello A, Bernardi G, Mercuri NB, Calabresi P. Chronic cocaine prevents depotentiation at corticostriatal synapses. Biol Psychiatry. 2006 Sep 1;60(5):436-43. doi: 10.1016/j.biopsych.2005.11.018. Epub 2006 Feb 14.

  PMID: 16476411 BACKGROUND

• Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.

  PMID: 18566003 BACKGROUND

• Figiel GS, Epstein C, McDonald WM, Amazon-Leece J, Figiel L, Saldivia A, Glover S. The use of rapid-rate transcranial magnetic stimulation (rTMS) in refractory depressed patients. J Neuropsychiatry Clin Neurosci. 1998 Winter;10(1):20-5. doi: 10.1176/jnp.10.1.20.

  PMID: 9547462 BACKGROUND

MeSH Terms

Conditions

Dystonic Disorders; Dystonia, Focal, Task-Specific

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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: March 5, 2014
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06-20

Locations

US (1)