Cervical Dystonia Clinical Trial
Official title:
Pre-injection, Multi-channel EMG Mapping to Optimize Botulinum Toxin Type A Efficacy in Cervical Dystonia.
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.
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.
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