Plasticity in Cervical Dystonia
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|ClinicalTrials.gov Identifier: NCT00323765|
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : July 2, 2017
|First Submitted Date||May 9, 2006|
|First Posted Date||May 10, 2006|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||May 5, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00323765 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Plasticity in Cervical Dystonia|
|Official Title||Plasticity in Cervical Dystonia|
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.
The main objective of this proposal is to evaluate plasticity in patients with cervical dystonia. Neither abnormal Hebbian nor non-Hebbian plasticity has been studied for cervical dystonia.
Our specific objectives are to show that:
We will study 22 patients with cervical dystonia and 22 healthy subjects for a total of 44 subjects.
Subjects will participate in 4 different sessions:
Visit 1: clinical screening (1 hour) and sensory evoked potential (SEP) assessment (2 hours, total of 3 hours).
Visit 2: PAS session of the target muscle and monitoring of cortical excitability before (T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4 hours).
Visit 3: TENS session of the target muscle and monitoring of cortical excitability before (T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4 hours).
Visit 4: DS session of the target and monitoring of cortical excitability before (T0), immediately after (T1), 45 minutes after (T2) and 90 minutes after T(3) (Total of 4 hours).
The electrophysiological effects of the interventions will be assessed by the size of motor evoked potentials (MEP), resting and active motor threshold (RMT and AMT), and a transcranial magnetic stimulation (TMS) input-output curve. The activity of intracortical interneurons mediating long intracortical inhibition (LICI) will be assessed by paired-pulse TMS. The effect of afferent input on intracortical processes (long afferent inhibition, LAI) will be assessed by stimulating the skin overlying the sternocleidomastoid muscle (SCM).
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Nutt JG, Muenter MD, Melton LJ 3rd, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol. 1988;50:361-5.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||May 20, 2008|
|Primary Completion Date||Not Provided|
The following exclusion criteria are due to the use of transcranial magnetic stimulation:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||060157
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 20, 2008|