NIH Clinical Research Studies

Protocol Number: 06-N-0128

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Title:
fMRI Studies of Task Specificity in Focal Hand Dystonia
Number:
06-N-0128
Summary:
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms.

Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test.

All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Focal Dystonia Subjects must be:

- Right hand dominant

- Between 18 and 65 years old

- Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively

- Willing to abstain from alcohol 48 hours prior to the study

Volunteers must be:

- Healthy right-handed dominant individuals

- Between 18 and 65 years old

- Willing to abstain from alcohol 48 hours prior to the study

EXCLUSION CRITERIA:

- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI

- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan

- Subjects who are pregnant.

- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes

- Subjects with any visual, motor, or hearing difficulties

- Subjects with severe focal hand dystonia i.e., subjects who experience dystonic spasms in tasks other than/in addition to writing

- Subjects with mirror dystonia

- Subjects without the capacity to give consent

- Subjects with any history of a severe medical condition, such as cardiovascular disease, which will prevent them from lying flat for up to 60 minutes.

- Subjects with any history of brain tumor, stroke, head trauma or vascular malformation as obtained by history or from imaging studies.

- Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections.

- Subjects who are on anti-parkinsonian drugs

Special Instructions:
Currently Not Provided
Keywords:
Imaging Studies
Botulinum Toxin
Writer's Cramp
Recruitment Keyword(s):
Focal Hand Dystonia
FHD
Writer Cramp
Healthy Volunteer
HV
Condition(s):
Focal Dystonia
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212.

Butterworth S, Francis S, Kelly E, McGlone F, Bowtell R, Sawle GV. Abnormal cortical sensory activation in dystonia: an fMRI study. Mov Disord. 2003 Jun;18(6):673-82.

Blood AJ, Flaherty AW, Choi JK, Hochberg FH, Greve DN, Bonmassar G, Rosen BR, Jenkins BG. Basal ganglia activity remains elevated after movement in focal hand dystonia. Ann Neurol. 2004 May;55(5):744-8.

Active Accrual, Protocols Recruiting New Patients

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