Focal Dystonia Clinical Trial
Official title:
The Role of Cortical Coherence in Focal Hand Dystonia
Verified date | April 27, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will use various methods to measure the activity of the motor cortex (the part of
the brain that controls movements) in order to learn more about focal hand dystonia. Patients
with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or
abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or
face, is involved.
Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of
age may be eligible for this study. Each candidate is screened with a medical history,
physical examination and questionnaire. Participants undergo the following procedures:
Finger Movement Tasks
Subjects perform two finger movement tasks. In the first part of the study, they move their
index finger repetitively from side to side at 10-second intervals for a total of 200
movements in four blocks of 50 at a time. In the second part of the study, subjects touch
their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats
2 times per second to help time the movements. This sequence is repeated for a total of 200
movements in four blocks of 50 at a time.
Electroencephalography
This test records brain waves. Electrodes (metal discs) are placed on the scalp with an
electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the
scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while
the subject performs a finger movement task, as described above.
Magnetoencephalography
MEG records magnetic field changes produced by brain activity. During the test, the subjects
are seated in the MEG recording room and a cone containing magnetic field detectors is
lowered onto their head. The recording may be made while the subject performs a finger task.
Electromyography
Electromyography (EMG) measures the electrical activity of muscles. This study uses surface
EMG, in which small metal disks filled with a conductive gel are taped to the skin on the
finger.
Magnetic resonance imaging
MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The
patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder),
wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning.
Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30
minutes at a time, and can communicate with the MRI staff at all times during the procedure.
Questionnaire
This questionnaire is designed to detect any sources of discomfort the subject may have
experienced during the study.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 27, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: - Normal subjects: Healthy volunteers ages 18 and older who consent to participate in the study - Patients ages 18 and older diagnosed with focal hand dystonia unilateral focal hand dystonia who consent to participate in the study EXCLUSION CRITERIA: - Normal subjects: abnormal neurologic exam or history of previous neurological disease that might affect the functioning of the hands - Dystonia patients: presence of a second neurologic disease or condition that might affect the functioning of the hands; abnormal neurologic findings on exam not related to the focal hand dystonia that might affect the functioning of the hands; the use of Botulinum toxin within 3 months prior to study participation - For MRI studies, patients with metallic implants will be excluded to avoid potential risks from this procedure - For MRI studies, women who are pregnant are excluded from this part of the protocol. All women of childbearing potential will have a pregnancy test performed prior to MRI studies, which must be negative, before proceeding. |
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,
Abbruzzese G, Berardelli A. Sensorimotor integration in movement disorders. Mov Disord. 2003 Mar;18(3):231-40. Review. — View Citation
Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. — View Citation
Andres FG, Gerloff C. Coherence of sequential movements and motor learning. J Clin Neurophysiol. 1999 Nov;16(6):520-7. Review. — View Citation
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