Healthy Volunteers Clinical Trial
Official title:
Loss of Depotentiation in Focal Dystonia
Verified date | April 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background
Focal dystonia is a brain disorder. It affects a muscle or muscles in a specific part of the
body. Researchers think it may be related to excessive training or practice. They want to
know more about how much training might trigger focal dystonia.
Objectives:
To study why people develop focal dystonia. To study how brain plasticity changes with focal
dystonia.
Eligibility:
People at least 18 years of age with focal dystonia.
Healthy volunteers the same age are also needed.
Design:
Participants will be screened with a physical exam and questions. They may have blood and
urine tests.
Participants will have up to 3 testing visits.
Participants will have small electrodes stuck on the skin on the hands or arms. Muscle
activity will be recorded.
Participants will have transcranial magnetic stimulation (TMS). A wire coil will be placed
onto the scalp. A brief electrical current will pass through the coil. The current will
create a magnetic field that affects brain activity.
Participants may be asked to tense certain muscles or do simple actions during TMS.
A nerve at the wrist will get weak electrical stimulation. The stimulation may be paired with
TMS for very short times.
Participants will receive repeated magnetic pulses. Participants will receive a total of 150
pulses during a 10-second period. An entire testing visit will last about 3 hours.
...
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 9, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
- INCLUSION CRITERIA: Inclusion criteria for healthy controls: - At least 18 years old.* - Able to give informed consent. - Able to comply with all study procedures. - Abstain from alcohol for at least 48 hours prior to each study visit and caffeine on the day of the visit. - Have no neurological or psychiatric disorders established by history and physical/neurological examination. - = A maximum of 10 subjects who are over the age of 70 will be screened for plasticity. If none of these subjects have plasticity, we will not accrue any more subjects over the age of 70. Inclusion criteria for focal dystonia patients: - At least 18-years old.* - Able to give informed consent. - Able to comply with all study procedures. - Abstain from alcohol for at least 48 hours prior to each visit of the study and caffeine on the day of the visit. - Have an established diagnosis of focal dystonia. - No botulinum toxin injections at least in the past 3 months. - = A maximum of 10 subjects who are over the age of 70 will be screened for plasticity. If none of these subjects have plasticity, we will not accrue any more subjects over the age of 70. EXCLUSION CRITERIA: - Self-reported consumption of > 14 alcoholic drinks/week for a man and > 7 alcoholic drinks/week for a woman. - Focal dystonia patients: presence of abnormal findings on neurological examination except for the diagnosis of focal dystonia. Healthy volunteers: no abnormal findings on neurological examination. - History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures. - Have a Baclofen pump, or have neurostimulators for pain. - Pregnant or breastfeeding women. - Current episode of major depression or any major psychiatric illness. - Presence of any metal in the eye or skull area such as a brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye. - Presence of pacemaker, intracardiac lines, implanted pumps or stimulators. - Known hearing loss. - Cognitive impairment. - NIH staff from HMCS. Healthy Volunteers: -Taking medications that act directly on the central nervous system such as anti- epileptics, anti-histamines, anti-parkinsonian medication, medication for insomnia, anti-depressants, anti-anxiety medication. Focal Dystonia Patients: -Taking medications that act directly on the central nervous system such as anti- epileptics, anti-parkinsonian medication, medication for insomnia. NOTE: Patients taking anti-histamines, anti-depressants or anti-anxiety medications will not be excluded from the protocol. However, only patients who have mild symptoms and agree to temporarily stop the medications during the experiment will be included. Patients with mild symptoms of depression will be confirmed using Hamilton Depression Rating Scale with total scores below 13. Patients with mild symptoms of anxiety will be confirmed using Hamilton Anxiety Rating Scale with total scores below 17. Patients will be required to stop their medication at least 5 half- lives of the drug, but no longer than 5 days (even if the half-life is longer than 24 hours) before each experimental session. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MEP amplitude immediately after the PAS25-cTBS150 (depotentiation) protocol | compare MEP amplitude in patients with that in healthy volunteers to identify whether depotentiation is weaker in focal dystonia | throughout | |
Secondary | MEP amplitudes | MEP amplitudes at other time points after the PAS25-cTBS150 procedure | throughout |
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