NCT00376753

Brief Summary

This study will examine and compare brain activity in people with focal hand dystonia (FHD) and healthy volunteers to obtain further knowledge about the underlying cause of FHD. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement; FHD affects the hands and fine finger movements. During fine finger movement, the brain controls muscles in a process called surround inhibition. This process may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles and impairing motor function. Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study. Candidates are screened with a physical and neurological examination. In a series of three experiments conducted during a single clinic visit, participants undergo transcranial magnetic stimulation (TMS) while performing a finger movement. A wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject is asked to contract one finger. In addition to TMS, subjects have surface electromyography. For this test, they sit in a chair with their hands placed on a pillow on their lap. The electrical activity of three muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin over the muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 11, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2011

Completed
Last Updated

July 2, 2017

Status Verified

May 11, 2011

First QC Date

September 14, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Transcranial Magnetic Stimulation (TMS)Writer's CrampElectromyogramFocal Hand DystoniaFHDHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • PATIENTS:
  • years old or older
  • Presence of FHD, for Experiment 5, 6, 7 and 8 the affected limb has to be the right and dominant side
  • HEALTHY VOLUNTEERS:
  • years old or older
  • Right handedness
  • Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems

You may not qualify if:

  • PATIENTS AND HEALTHY VOLUNTEERS:
  • Concurrent significant medical, surgical, neurological or psychiatric condition
  • Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
  • Patients- Received botulinum toxin injection within 3 months of starting the protocol
  • For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
  • History of seizure disorder
  • Known history of hearing loss
  • For MRI: Presence of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.
  • Pregnancy.

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)

  • 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. doi: 10.1093/brain/121.7.1195.

    PMID: 9679773BACKGROUND
  • Bressman SB, de Leon D, Raymond D, Greene PE, Brin MF, Fahn S, Ozelius LJ, Breakefield XO, Kramer PL, Risch NJ. The role of the DYT1 gene in secondary dystonia. Adv Neurol. 1998;78:107-15. No abstract available.

    PMID: 9750907BACKGROUND
  • Defazio G, Aniello MS, Masi G, Lucchese V, De Candia D, Martino D. Frequency of familial aggregation in primary adult-onset cranial cervical dystonia. Neurol Sci. 2003 Oct;24(3):168-9. doi: 10.1007/s10072-003-0113-3.

    PMID: 14598070BACKGROUND

MeSH Terms

Conditions

Dystonia, Focal, Task-SpecificDystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

September 11, 2006

Study Completion

May 11, 2011

Last Updated

July 2, 2017

Record last verified: 2011-05-11

Locations