Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:11/7/2018
Start Date:March 2014
End Date:July 2019
Contact:Mary Catherine George
Email:mary-catherine.george@mssm.edu
Phone:212-241-0784

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A Placebo-Controlled, Double-Blind, Randomized, Cross Over Pilot Study Of The Efficacy And Tolerability Of Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand

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.


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.
We found this trial at
2
sites
462 1st Avenue
New York, New York 10010
Principal Investigator: Steven Frucht, MD
Phone: 929-455-5648
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: David M Simpson, MD
Phone: 212-241-0784
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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