NCT00325091

Brief Summary

This study will examine the effects of long-term practice of repeated finger movements in people with focal hand dystonia, as compared with healthy volunteers. 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. Right-handed healthy volunteers and patients with focal hand dystonia of the right hand 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and neurological and physical examination. Participants are trained daily for 11 days (excluding weekends) at the NIH and are asked to continue with daily 15 minutes of practice over a 12-week period to perform sequential finger movement task (key presses) with their left hand. They practice initially at NIH and then at home. At each clinic visit, their learning of the motor skill is assessed by recording their performance of 20 consecutive trials of the eight sequences (a total of 160 key presses) in the task. To evaluate long-term motor learning of the sequential movements, participants are asked to do different task tests at Day 2, Week 4 and Week 12. Brain wave activity, and brain excitability are also measured during these days. In one task, they see a random series of letters on a screen during the sequential finger movements and are asked to say the number of times they see a specific letter. In another task, they are asked to focus on each specific movement while performing the sequential finger movements. During each visit, they are questioned and evaluated for the development of any abnormal movements that may be suggestive of early dystonia. All participants have an electroencephalogram (EEG) and transcranial magnetic stimulation (TMS) at Day 1, and Day 2 and at Week 4 and Week 12 to evaluate brain activity. For the EEG, electrodes are placed on the subject's scalp and the electrical activity of the brain is recorded while the subject performs the sequence of finger movements. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The effect of TMS on the muscles is detected with small electrodes taped to the skin of the subject's arms or legs. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2014

Completed
Last Updated

December 17, 2019

Status Verified

January 6, 2014

First QC Date

May 11, 2006

Last Update Submit

December 14, 2019

Conditions

Keywords

Writer's CrampElectroencephalogram (EEG)Transcranial Magnetic Stimulation (TMS)Fine Motor SkillsFocal Hand DystoniaWriter CrampHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • Age 18 years and older
  • Right-hand dominant (Edinburgh Handedness Quotient greater than 60)
  • Able to provide consent for the protocol
  • Patients:
  • Age 18 years and older
  • Right hand dominant (Edinburgh Handedness Quotient greater than 60)
  • Idiopathic focal hand dystonia in right hand
  • Able to provide consent for the protocol

You may not qualify if:

  • Subjects with other medical, surgical, neurologic or psychiatric conditions
  • If participants are taking certain centrally acting medications (like antidepressants, anxiolytics/neuroleptics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines) may not be eligible to participate in this study.
  • The presence of a cardiac pacemaker, an implanted medical pump, a metal plate or metal object in skull or eye is contraindications for TMS application.
  • Patients with seizure disorder or epilepsy
  • Subjects without the capacity to give informed consent
  • If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension
  • Patients:
  • Subjects with any abnormal findings on neurological examination (except right hand), and general physical examination
  • Secondary hand dystonia
  • Healthy volunteers:
  • Subjects with any abnormal findings on neurological examination and general physical examination
  • Subjects who have learned to play the piano or any other keyboard instrument in the past.
  • Subjects who have jobs or are involved in daily activities that demand skilled, fine-finger movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Agostino R, Berardelli A, Formica A, Accornero N, Manfredi M. Sequential arm movements in patients with Parkinson's disease, Huntington's disease and dystonia. Brain. 1992 Oct;115 ( Pt 5):1481-95. doi: 10.1093/brain/115.5.1481.

    PMID: 1422799BACKGROUND
  • Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.

    PMID: 10355671BACKGROUND
  • Byl NN, Merzenich MM, Jenkins WM. A primate genesis model of focal dystonia and repetitive strain injury: I. Learning-induced dedifferentiation of the representation of the hand in the primary somatosensory cortex in adult monkeys. Neurology. 1996 Aug;47(2):508-20. doi: 10.1212/wnl.47.2.508.

    PMID: 8757029BACKGROUND

MeSH Terms

Conditions

Dystonia, Focal, Task-SpecificDystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Start

May 9, 2006

Study Completion

January 6, 2014

Last Updated

December 17, 2019

Record last verified: 2014-01-06

Locations