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fMRI Studies of Task Specificity in Focal Hand Dystonia

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00310414
First received: March 31, 2006
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition
Focal Dystonia

Study Type: Observational
Official Title: fMRI Studies of Task Specificity in Focal Hand Dystonia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 51
Study Start Date: March 2006
Estimated Study Completion Date: March 2012
Detailed Description:

Objective:

Writer's cramp, a form of focal hand dystonia, is the most frequently observed task specific dystonia. Symptoms of writer's cramp often appear as soon as the pen is picked up, or after a few words of writing. Patients with simple writer's cramp have difficulties writing, but carry out other tasks with the affected hand without spasms. Little is known about why the hand spasms when writing, while performing other tasks normally.

The purpose of this study is to identify brain areas of activation associated specifically with the task of handwriting with the dystonic hand, in patients with simple writer's cramp. Simple writer's cramp can be defined by a patient exhibiting the symptoms only when writing and symptoms are not present in any other task performance. Specifically for this study, patients should be able to write for 20 seconds consecutively in a run. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when different tasks are performed by different limbs in healthy volunteers and patients with focal hand dystonia.

Study Population:

This research will be conducted using 22 patients diagnosed with simple writer's cramp and 32 healthy volunteers matched for age and gender.

Design:

Using a block design in functional magnetic resonance imaging (fMRI), we will examine the brain activity of patients and healthy volunteers while they execute three tasks: writing, tapping and a zigzagging motion, with three separate limbs: the dystonic hand, the opposite hand, and the right foot.

Outcome Measures:

The changes in signal intensity of the brain activity correlated with the motor program (task of handwriting) and effector (dystonic hand) will be collected and analyzed.

The findings we expect to obtain with this experiment may contribute to basic knowledge of the linkage between task specificity and the dystonic hand, and may provide a better understanding of the pathophysiology of writer's cramp.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310414

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth H Fischbeck, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00310414     History of Changes
Other Study ID Numbers: 060128, 06-N-0128
Study First Received: March 31, 2006
Last Updated: March 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Imaging Studies
Botulinum Toxin
Writer's Cramp
Focal Hand Dystonia
FHD
Writer Cramp
Healthy Volunteer
HV

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014