NCT00323765

Brief Summary

This study will identify changes that occur in the part of the brain that controls hand movements in patients with cervical (neck) dystonia. 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. The study will compare findings in healthy volunteers and patients with cervical dystonia to learn more about the condition. Healthy volunteers and patients with cervical dystonia 18 years of age and older may be eligible to participate. Candidates are screened with a medical history and physical examination. Participants undergo the following tests: Somatosensory evoked potentials (Visits 1 and 2) This test examines how sensory information travels from the nerves to the spinal cord and brain. An electrode placed on an arm or leg delivers a small electrical stimulus and additional electrodes placed on the scalp, neck and over the collarbone record how the impulse from the stimulus travels over the nerve pathways. Transcranial Magnetic Stimulation (Visits 2, 3 and 4) This procedure maps brain function. A wire coil is held on the scalp. A brief electrical current passes through the coil, creating a magnetic pulse that stimulates the brain. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. Nerve conduction studies (Visits 2, 3 and 4) This test measures how fast nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. Nerves are stimulated through small wire electrodes attached to the skin and the response is recorded and analyzed. Surface electromyography (Visits 2, 3 and 4) Electrodes are placed on the front and back of the neck muscles to measure the electrical activity of the muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Typical duration 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 5, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

May 20, 2008

First QC Date

May 9, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Transcranial Magnetic Stimulation (TMS)Cervical DystoniaPlasticityHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers (aged 18 or older) who are willing to participate
  • Patients (aged 18 and older) with idiopathic cervical dystonia that show a clear asymmetric involvement of the SCM muscles with lateral rotation of the head in the coronal or longitudinal plane

You may not qualify if:

  • Subjects with additional significant neurological disorder, current use or a history of alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment such as substance abuse addiction, head injury with loss of consciousness, epilepsy.
  • Subjects with significant hearing loss
  • Subjects receiving drugs with significant action on the central nervous system
  • Subjects who have been treated with botulinum toxin injections less than 3 months prior to their participation in the study
  • Subjects who are taking any oral medication for dystonia at the time of the study
  • Subjects with cardiac pacemakers, implanted medication pumps
  • Subjects with eye, blood vessel, cochlear, or eye implants
  • Subjects with increased intracranial pressure as evaluated by clinical means
  • Subjects with metal in the cranium
  • Subjects with dental braces (but dental fillings are acceptable), metal fragments from occupational exposure or surgical clips in or near the brain

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 (1)

  • Nutt JG, Muenter MD, Melton LJ 3rd, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol. 1988;50:361-5. No abstract available.

    PMID: 3400496BACKGROUND

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 10, 2006

Study Start

May 5, 2006

Study Completion

May 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-05-20

Locations