- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02106936
Depotentiation in People With Focal Hand Dystonia
Depotentiation in Focal Hand Dystonia Patients
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.
Study Overview
Status
Conditions
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:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor evoked potential amplitude
Time Frame: Immediate
|
Immediate
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140070
- 14-N-0070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States