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Sponsors and Collaborators: |
University of California, San Francisco Allergan |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00773253 |
The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.
Condition | Intervention | Phase |
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Cervical Dystonia |
Drug: Botulinum toxin A |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | Pre-Injection, Multi-Channel EMG Mapping to Optimize Botulinum Toxin Type A Efficacy in Cervical Dystonia. |
Estimated Enrollment: | 10 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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standard EMG-guided Botox injection: Active Comparator
All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
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Drug: Botulinum toxin A
All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
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Multi-channel EMG-guided Botox injection: Experimental
Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
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Drug: Botulinum toxin A
All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
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The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal response to Botulinum toxin therapy. It is unclear why some patients do not respond maximally to neurotoxin therapy.
Studies using needle electromyographic "mapping" in the evaluation of cervical dystonia have revealed that clinical examination alone is insufficient for determining which muscles contribute to the dystonic movement. When compared to needle electromyography (EMG) "mapping studies", experienced movement disorders specialists correctly identify only 59% of active muscles and believe that 25% of muscles which upon EMG evaluation are found to be quiescent, are involved in the dystonia. The selection of incorrect muscles for injection of Botulinum toxin may explain why some patients have a sub-optimal response.
This study seeks to measure outcomes when the muscles involved in dystonia are identified using "mapping" via an 8-12 channel EMG. In the proposed study, the most involved/active dystonic muscles will be correctly identified through simultaneous 8-12 channel mapping resulting in a more informed injection strategy, which may improve response to Botulinum toxin A treatment as compared to single lead EMG based injections. This study changes routine clinical care only by adding the step of studying the muscles of the neck with simultaneous EMG mapping to allow a more objective injection strategy.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contact: Jamie Grace, B.S. | 415-353-8328 | jamie.grace@ucsf.edu |
Contact: Graham A. Glass, M.D. | 415-221-4810 ext 2657 | graham.glass@ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Jamie Grace, B.S. 415-353-8328 jamie.grace@ucsf.edu | |
Contact: Graham A. Glass, M.D. 415-221-4810 ext 2657 graham.glass@ucsf.edu | |
Principal Investigator: Graham A. Glass, M.D. | |
San Francisco Veterans Administration Medical Center | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Susan Heath, M.S.N. 415-221-4810 ext 2505 Susan.Heath@va.gov |
Responsible Party: | University of California, San Francisco ( Graham A. Glass, M.D. ) |
Study ID Numbers: | Allergan cervical dystonia |
Study First Received: | October 14, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00773253 |
Health Authority: | United States: Institutional Review Board |
dystonia cervical dystonia Botox idiopathic primary cervical dystonia |
Dystonic Disorders Signs and Symptoms Torticollis Botulinum Toxins Movement Disorders |
Central Nervous System Diseases Neurologic Manifestations Dystonia Botulinum Toxin Type A Dyskinesias |
Anti-Dyskinesia Agents Therapeutic Uses Nervous System Diseases Central Nervous System Agents Pharmacologic Actions |