Trial Outcomes & Findings for Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia (NCT NCT00208091)
NCT ID: NCT00208091
Last Updated: 2014-05-09
Results Overview
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.
COMPLETED
PHASE4
16 participants
Baseline and 6 weeks post-injection
2014-05-09
Participant Flow
The dates of recruitment for this study were from April 2003 to May 2008. Both male and female subjects were included. Each subject must have been diagnosed with a focal, task-specific dystonia which was clinically determined to be the result of a high level of musical skill and intensive performance history to be included in the study.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia
Baseline characteristics by cohort
| Measure |
Botulinum Toxin, Type B
n=16 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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14 Participants
n=99 Participants
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Age, Categorical
>=65 years
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2 Participants
n=99 Participants
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Age, Continuous
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49.375 years
STANDARD_DEVIATION 13.93 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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14 Participants
n=99 Participants
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Region of Enrollment
United States
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16 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and 6 weeks post-injectionNote 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.
Outcome measures
| Measure |
Note Errors (Related to Errors in Duration), Baseline
n=16 Participants
Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
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Note Errors (Related to Errors in Duration), Post-injection
n=16 Participants
Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
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|---|---|---|
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Note Errors (Related to Errors in Duration)
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8.20 msec
Standard Error 8.49
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5.79 msec
Standard Error 4.00
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PRIMARY outcome
Timeframe: Baseline and 6 weeks post-injectionNote 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.
Outcome measures
| Measure |
Note Errors (Related to Errors in Duration), Baseline
n=16 Participants
Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
|
Note Errors (Related to Errors in Duration), Post-injection
n=16 Participants
Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
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|---|---|---|
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Note Errors (Related to Errors in Loudness)
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10.06 decibels
Standard Error 1.28
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8.43 decibels
Standard Error 1.63
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SECONDARY outcome
Timeframe: Baseline to 6 weeks after injectionEach subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).
Outcome measures
| Measure |
Note Errors (Related to Errors in Duration), Baseline
n=16 Participants
Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
|
Note Errors (Related to Errors in Duration), Post-injection
Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
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Subjective Assessment Ratings of Change
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30 percentage change
Standard Deviation 29.3
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—
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Adverse Events
Botulinum Toxin, Type B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place