Cervical Dystonia Clinical Trial
Official title:
Plasticity in Cervical Dystonia
Verified date | May 20, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will identify changes that occur in the part of the brain that controls hand
movements in patients with cervical (neck) dystonia. Patients with dystonia have muscle
spasms that cause abnormal postures while trying to perform a movement. In focal dystonia,
just one part of the body, such as the hand, neck or face, is involved. The study will
compare findings in healthy volunteers and patients with cervical dystonia to learn more
about the condition.
Healthy volunteers and patients with cervical dystonia 18 years of age and older may be
eligible to participate. Candidates are screened with a medical history and physical
examination. Participants undergo the following tests:
Somatosensory evoked potentials (Visits 1 and 2)
This test examines how sensory information travels from the nerves to the spinal cord and
brain. An electrode placed on an arm or leg delivers a small electrical stimulus and
additional electrodes placed on the scalp, neck and over the collarbone record how the
impulse from the stimulus travels over the nerve pathways.
Transcranial Magnetic Stimulation (Visits 2, 3 and 4)
This procedure maps brain function. A wire coil is held on the scalp. A brief electrical
current passes through the coil, creating a magnetic pulse that stimulates the brain. The
stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear
a click and feel a pulling sensation on the skin under the coil.
Nerve conduction studies (Visits 2, 3 and 4)
This test measures how fast nerves conduct electrical impulses and the strength of the
connection between the nerve and the muscle. Nerves are stimulated through small wire
electrodes attached to the skin and the response is recorded and analyzed.
Surface electromyography (Visits 2, 3 and 4)
Electrodes are placed on the front and back of the neck muscles to measure the electrical
activity of the muscles.
Status | Completed |
Enrollment | 44 |
Est. completion date | May 20, 2008 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: - Healthy volunteers (aged 18 or older) who are willing to participate - Patients (aged 18 and older) with idiopathic cervical dystonia that show a clear asymmetric involvement of the SCM muscles with lateral rotation of the head in the coronal or longitudinal plane EXCLUSION CRITERIA: - Subjects with additional significant neurological disorder, current use or a history of alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment such as substance abuse addiction, head injury with loss of consciousness, epilepsy. - Subjects with significant hearing loss - Subjects receiving drugs with significant action on the central nervous system - Subjects who have been treated with botulinum toxin injections less than 3 months prior to their participation in the study - Subjects who are taking any oral medication for dystonia at the time of the study The following exclusion criteria are due to the use of transcranial magnetic stimulation: - Subjects with cardiac pacemakers, implanted medication pumps - Subjects with eye, blood vessel, cochlear, or eye implants - Subjects with increased intracranial pressure as evaluated by clinical means - Subjects with metal in the cranium - Subjects with dental braces (but dental fillings are acceptable), metal fragments from occupational exposure or surgical clips in or near the brain |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Nutt JG, Muenter MD, Melton LJ 3rd, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol. 1988;50:361-5. — View Citation
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