NCT00487383

Brief Summary

This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia. Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study. All candidates are screened with a medical history. People with blepharospasm also have a physical examination and blepharospasm rating. Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in two 4-hour sessions, separated by 1 to 7 days. 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 subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes. EMG Surface EMG is done during TMS to measure the electrical activity of muscles. For this test, electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the face.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 12, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2012

Completed
Last Updated

December 16, 2019

Status Verified

June 29, 2012

First QC Date

June 15, 2007

Last Update Submit

December 13, 2019

Conditions

Keywords

CerebellumTranscranial Magnetic Stimulation (TMS)BlepharospasmDYT-1 Generalized DystoniaFocal DystoniaDystoniaHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENTS:
  • Age 18 years or older
  • Normal findings in the medical history, physical and neurological examination, except for dystonia
  • HEALTHY CONTROLS:
  • Age 18 years or older
  • Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems

You may not qualify if:

  • Any of the following will exclude patients and controls from the study:
  • Secondary forms of dystonia, including tardive dyskinesia
  • History of seizure disorder
  • Symptoms of a clinically relevant illness in the 2 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications, anti-seizure medications, anticholinergic drugs, and muscle relaxants
  • Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
  • History of neuroleptic medications
  • Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
  • Botulinum toxin injection within 3 months of starting the protocol
  • Known hearing loss

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)

  • Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Sole J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433-44. doi: 10.1111/j.1468-1331.2006.01537.x.

    PMID: 16722965BACKGROUND
  • Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. doi: 10.1016/s0140-6736(05)71235-6. No abstract available.

    PMID: 11254003BACKGROUND
  • Aramideh M, Ongerboer de Visser BW, Holstege G, Majoie CB, Speelman JD. Blepharospasm in association with a lower pontine lesion. Neurology. 1996 Feb;46(2):476-8. doi: 10.1212/wnl.46.2.476.

    PMID: 8614517BACKGROUND

MeSH Terms

Conditions

DystoniaDystonic DisordersCerebellar DiseasesBlepharospasm

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System DiseasesBrain DiseasesEyelid DiseasesEye Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 18, 2007

Study Start

June 12, 2007

Study Completion

June 29, 2012

Last Updated

December 16, 2019

Record last verified: 2012-06-29

Locations