Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia - Full Text View

Purpose

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	Intervention	Phase
Focal Dystonia	Drug: Botulinum toxin, type B	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ®).

Resource links provided by NLM:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia task-specific focal dystonia

MedlinePlus related topics: Botox Dystonia

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Note Errors (Related to Errors in Duration) [ Time Frame: Baseline and 6 weeks post-injection ] [ Designated as safety issue: No ]
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.
Note Errors (Related to Errors in Loudness) [ Time Frame: Baseline and 6 weeks post-injection ] [ Designated as safety issue: No ]
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:

Subjective Assessment Ratings of Change [ Time Frame: Baseline to 6 weeks after injection ] [ Designated as safety issue: No ]
Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).


Enrollment:	16
Study Start Date:	April 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


Ages Eligible for Study:	25 Years to 69 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208091

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


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
Study First Received:	September 13, 2005
Results First Received:	August 22, 2013
Last Updated:	April 11, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 AbobotulinumtoxinA OnabotulinumtoxinA	IncobotulinumtoxinA 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

ClinicalTrials.gov processed this record on September 26, 2016