Dystonia Clinical Trial
Official title:
The Physiology of Tricks
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: 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. 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: Exclusion criteria for the trial covering both the normal control and dystonia group will include; 1. Any concurrent medical or surgical condition as well as neurological or psychiatric illnesses. 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. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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