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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Focal Dystonia	Drug: Botulinum toxin, type B	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open Label Evaluation of MIDI to Quantify Performance Change in Subjects With Musician's Dystonia After Treatment With Botulinum Toxin Type B (Myobloc ®).
Study Start Date :	April 2003
Actual Primary Completion Date :	May 2008
Actual Study Completion Date :	May 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Botulinum toxin, type B; Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.	Drug: Botulinum toxin, type B; Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.; Other Name: Myobloc

Outcome Measures

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Primary Outcome Measures :

1. Note Errors (Related to Errors in Duration) [ Time Frame: Baseline and 6 weeks post-injection ]
   Note errors (related to errors in duration in msec) were obtained as measures of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note output from four musical sequences of 8 to 16 notes played. It was calculated by averaging the sequences for each hand, and deriving the square root of the mean of the square of the differences (root mean square error, in msec) in MIDI.
2. Note Errors (Related to Errors in Loudness) [ Time Frame: Baseline and 6 weeks post-injection ]
   Note errors (related to errors in loudness) were obtained as a measure of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note loudness data (decibels) from four musical sequences of 8 to 16 notes. It was calculated by averaging sequences for each hand and taking the square root of the mean of the square of the differences (root mean square error, in decibels) in MIDI notes.

Secondary Outcome Measures :

1. Subjective Assessment Ratings of Change [ Time Frame: Baseline to 6 weeks after injection ]
   Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Neurological Institute, 710 W. 168th Street, NI-1112
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Solstice Neurosciences

Investigators

Principal Investigator:	Seth Pullman, MD	Columbia University Medical Center, Department of Neurology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Seth Pullman, Professor of Clinical, Department of Neurology, Movement Disorders, Columbia University
ClinicalTrials.gov Identifier:	NCT00208091 History of Changes
Other Study ID Numbers:	AAAB2808
First Posted:	September 21, 2005
Results First Posted:	May 9, 2014
Last Update Posted:	May 9, 2014
Last Verified:	April 2014

Keywords provided by Seth Pullman, Columbia University:

Myloboc; Botulinum Toxin Type B; Focal Dystonia; Musicians; Muscle Relaxants	Motor Impairments; Motor Performance; Tremor; Abnormal Postures

Additional relevant MeSH terms:

Dystonia; Dystonic Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA	abobotulinumtoxinA; rimabotulinumtoxinB; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents; Anti-Dyskinesia Agents