Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2003-11-30
2005-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Eligibility Criteria
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Inclusion Criteria
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.
Their gender, age, or ethnic origin will not provide bias for inclusion to the study.
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.
Exclusion Criteria
2. Any individual who is on medications with potential influence of the nervous system function (antidepressants, antianxiolytics, anticonvulsants, antipsychotic, antiparkinsonian, hypnotics, and stimulants).
3. Patients who have received Botulinum toxin injections within 3 months of starting the protocol.
4. 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)
5. Individual with a history of seizures.
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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04-N-0041
Identifier Type: -
Identifier Source: secondary_id
040041
Identifier Type: -
Identifier Source: org_study_id
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