Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Intervention: incobotulinumtoxin A; Placebo
Intervention description: Incobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.; matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Musician's Dystonia

Summary:

      The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®).
      Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves,
      inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In
      musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be
      critical for the musical professional to continue his or her career. With the use of
      EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize
      the individual muscles that are affected in this condition with great accuracy. Prior studies
      have shown that BoNT injections produce beneficial effects in forearm muscles, and less
      effect in shoulder or proximal arm muscles.

      Possible risks in treating patients with BoNT include excessive weakness of the injected
      muscles. The drug may also affect non-targeted muscles. However these risks will be minimized
      during the screening period by carefully targeting the affected muscles and by administering
      low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks
      after the primary injection date) if the initial injection was insufficient to produce
      sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of
      the targeted muscle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with focal task-specific dystonia of one or both hands, selectively triggered
             by performance on a musical instrument.

          -  Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of
             Mount Sinai Medical Center as part of their clinical care.

          -  Patients whose performance on an instrument is directly linked to their occupation.

          -  Patients must be between the ages of 18 and 80.

          -  Impairment in musical performance must be visible and demonstrable.

        Exclusion Criteria:

          -  Patients whose dystonia is not severe enough to interfere with musical performance in
             the opinion of a skilled examiner.

          -  Patients with unstable medical conditions or psychiatric conditions.

          -  Patients with a medical condition that precludes them from receiving BoNT injections.