Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00208091
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Collaborator:
Solstice Neurosciences
Information provided by (Responsible Party):
Seth Pullman, Columbia University

Study Description
Go to 
Top of Page 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

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 69 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208091


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Seth Pullman, MD Columbia University Medical Center, Department of Neurology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal 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    Key Record Dates
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:
Layout table for MeSH terms
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
rimabotulinumtoxinB
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
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