Phase 4 N=16 Treatment

Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia

Focal Dystonia

Bottom Line

View on ClinicalTrials.gov: NCT00208091 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Note Errors (Related to Errors in Duration) — 8.20; 5.79 msec — p==0.06

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Botulinum toxin, type B (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Note Errors (Related to Errors in Duration)	8.20; 5.79	=0.06
PRIMARY Note Errors (Related to Errors in Loudness)	10.06; 8.43	=0.23
SECONDARY Subjective Assessment Ratings of Change	30	—

Summary

This study uses a computerized method of musical instrument digital interface (MIDI) quantification of performance before and after treatment with botulinum toxin type B (Myobloc ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used medically to relax unwanted muscle spasms and movements. The aim of the study is to determine the feasibility of quantifying change in performance following treatment.

Eligibility Criteria

Inclusion Criteria

Focal, task-specific dystonia clinically determined to be the result of a high level of musical skill and intensive performance history

Exclusion Criteria

Neurological disorders other than dystonia
Patients who are clinically depressed, demented or otherwise unable to perform appropriately or sit through 1 hour of testing
Patients who have undergone pallidotomy, thalamotomy or deep brain stimulator implantations
Patients who have who recently have taken medications with extrapyramidal or tremorogenic side effects

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00208091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.