Brief Summary

This study will examine the action of sensory tricks on an occurrence known as surround inhibition when there is a disorder of muscle tone affecting a single body part in isolation. Surround inhibition refers to a situation that suppresses unwanted movements, known as dystonia, in surrounding muscles during voluntary actions. There are tricks-various actions-that people use to temporarily stop those unwanted movements. Such tricks can include touching the affected body part, placing an object in the mouth, pulling the hair, and others. Often these tricks are beneficial early in the illness but become less effective as it progresses. This study is guided by a hypothesis that sensory tricks will restore surround inhibition and by another hypothesis that it is the application of the tricks, not simply sensory input, that is effective in doing that restoring. Emphasis is on cervical dystonia, involuntary actions affecting the neck, in which the tricks commonly involve the cheeks and chin. The technique used in the study is transcranial magnetic stimulation (TMS). Patients ages 18 and older who have cervical dystonia with at least one effective trick and patients with no effective trick may be eligible for this study. There will also be a control group of healthy participants. Participants will be asked to show the sensory trick and may be asked to be videotaped. During the TMS procedure, they will be seated in a comfortable chair, with hands placed on a pillow on the lap. Small electrodes-soft strips that stick to the skin-will be placed on the skin to record the electrical activity of some muscles in the neck that are activated by the stimulation from TMS. In TMS, there will be a wire coil held over the scalp. A brief electrical current will be passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click and may feel a pulling sensation on the skin under the coil. There may be muscle twitches of the face, arm, or leg. In addition, patients may be asked to tense certain muscles slightly or perform other simple actions so that the coil can be positioned appropriately. Patients will sometimes be asked to bite down and tap their teeth slightly for about 1-1/2 minutes at a time. They will be asked to show the sensory trick. The stimulation is usually not painful, although sometimes strong contractions of the scalp muscles can cause discomfort or a headache. Patients can ask to have the procedure discontinued at any time. The testing session takes about 2 hours, done on an outpatient basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2005

First QC Date

November 12, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

Transcranial Magnetic StimulationTorticollisCervical DystoniaSurround InhibitionSensory Tricks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nineteen patients age 18 or over with cervical dystonia with a minimal of one effective trick, 15 patients age 18 and over with cervical dystonia with no effective trick will be recruited for the study.
  • For patients, the selection criteria are the presence of cervical dystonia and the minimal of one sensory trick in the patient with trick group, and no trick in the patient without trick group.
  • The interview of dystonic patients will be focused on medical history, neurologic examination and effectiveness of the patient's tricks which will be accessed by measuring the degree of head rotation before and during trick application.
  • The diagnosis of dystonia will rely on review of medical record, history, and clinical evaluation.
  • For the patients that are receiving botulinum toxin injections, the evaluation will be done 3 months after their last injection.
  • There is no evidence of higher prevalence of dystonia in any particular race, thus the races and ethnicity of the subjects recruited for this study will approximate that of the general population.
  • Fifteen normal subjects age 18 and over will be recruited for the control group.
  • The controls will not have dystonia or any other neurological condition.
  • All subjects will sign an informed consent prior to participation in the trial, and the trial will be approved by the NINDS IRB committee.

You may not qualify if:

  • Any concurrent medical or surgical condition as well as neurological or psychiatric illnesses.
  • Any individual who is on medications with potential influence of the nervous system function (antidepressants, antianxiolytics, anticonvulsants, antipsychotic, antiparkinsonian, hypnotics, and stimulants).
  • Patients who have received Botulinum toxin injections within 3 months of starting the protocol.
  • Individual who has a pacemaker, an implanted medical pump, a metal plate or medical object in the skull or eye (for example, after brain surgery)
  • Individual with a history of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.

    PMID: 11222454BACKGROUND
  • Bara-Jimenez W, Shelton P, Sanger TD, Hallett M. Sensory discrimination capabilities in patients with focal hand dystonia. Ann Neurol. 2000 Mar;47(3):377-80.

    PMID: 10716260BACKGROUND
  • 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

MeSH Terms

Conditions

DystoniaTorticollis

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 12, 2003

First Posted

November 13, 2003

Study Start

November 1, 2003

Study Completion

October 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-10

Locations