Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia
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ClinicalTrials.gov Identifier: NCT00208091 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
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Condition or disease | Intervention/treatment | Phase |
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Focal Dystonia | Drug: Botulinum toxin, type B | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
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 |

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.
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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 |
- 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.
- 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.
- 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).

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

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
United States, New York | |
Neurological Institute, 710 W. 168th Street, NI-1112 | |
New York, New York, United States, 10032 |
Principal Investigator: | Seth Pullman, MD | Columbia University Medical Center, Department of Neurology |
Responsible Party: | Seth Pullman, Professor of Clinical, Department of Neurology, Movement Disorders, Columbia University |
ClinicalTrials.gov Identifier: | NCT00208091 |
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 |
Myloboc Botulinum Toxin Type B Focal Dystonia Musicians Muscle Relaxants |
Motor Impairments Motor Performance Tremor Abnormal Postures |
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Movement Disorders Central Nervous System Diseases |
Botulinum Toxins Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |