Depotentiation in People With Focal Hand Dystonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Prachaya Srivanitchapoom, MD
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT02106936
First received: April 3, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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.

Condition
Focal Dystonia
Healthy Volunteers

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Depotentiation in Focal Hand Dystonia Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Motor evoked potential amplitude [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Objectives:

Primary objectives:

To explore the proper parameters creating a long-term depression (LTD)-like effect and depotentiation (DePo) by using rapid paired associative stimulation (rPAS) in focal hand dystonia (FHD) patients

Sample Size and Population:

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We plan to recruit 28 healthy volunteers (HVs) and 28 FHD patients from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS.

Design:

Phase 1 deals with HVs while phase 2 deals with FHD patients. We will complete phase 1 before starting phase 2. Each phase is composed of 2 experiments. In phase 1, experiments 1 and 2 will create the LTD-like effect and DePo in HVs and in phase 2, experiments 3 and 4 will elicit the LTD-like effect and DePo in FHD patients. We will use regression analysis to show that the motor evoked potential (MEP) amplitude declines after eliciting the LTD-like effect and DePo.

Outcome measurements:

Primary outcome:

Determining the parameters for creating the LTD-like effect and DePo in HVs and FHD using rPAS

Secondary outcome:

Measuring the percent change of the MEP amplitude after applying the proper stimulus parameters causing an LTD-like effect and DePo in both HVs and FHD.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106936

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Prachaya Srivanitchapoom, MD
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT02106936     History of Changes
Other Study ID Numbers: 140070, 14-N-0070
Study First Received: April 3, 2014
Last Updated: April 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Focal Hand Dystonia
Depotentiation
Transcranial Magnetic Stimulation (TMS)
Rapid Paired Associative Stimulation
Healthy Volunteer

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014