Depotentiation in People With Focal Hand Dystonia
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/23/2017 |
| Start Date: | March 5, 2014 |
| End Date: | June 20, 2017 |
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.
- 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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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