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

NCT00208091 | Completed Phase 4 Results

• 1 other identifier: AAAB2808
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Dystonia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Note Errors (Related to Errors in Duration)

  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.

  Baseline and 6 weeks post-injection

• Note Errors (Related to Errors in Loudness)

  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.

  Baseline and 6 weeks post-injection

Secondary Outcomes (1)

• Subjective Assessment Ratings of Change

  Baseline to 6 weeks after injection

Study Arms (1)

Botulinum toxin, type B

EXPERIMENTAL

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

Interventions

Botulinum toxin, type B DRUG

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.

Also known as: Myobloc

Botulinum toxin, type B

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Solstice Neurosciences: collaborator

Study Sites (1)

Neurological Institute, 710 W. 168th Street, NI-1112

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Dystonic Disorders; Muscle Hypotonia; Tremor

Interventions

rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Results Point of Contact

• Title: Dr. Seth Pullman
• Organization: Clinical Motor Physiology Laboratory

sp31@columbia.edu

212-305-3808

Study Officials

• Seth Pullman, MD

  Columbia University Medical Center, Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical, Department of Neurology, Movement Disorders

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (1)