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Trial record 59 of 260 for:    "dopa-responsive dystonia" OR "Dystonia"

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
Sponsor:
Collaborator:
Solstice Neurosciences
Information provided by (Responsible Party):
Seth Pullman, Columbia University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Focal Dystonia
Intervention Drug: Botulinum toxin, type B
Enrollment 16
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Botulinum Toxin, Type B
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Botulinum Toxin, Type B
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  87.5%
>=65 years
2
  12.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
49.375  (13.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
2
  12.5%
Male
14
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Note Errors (Related to Errors in Duration)
Hide Description 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.
Time Frame Baseline and 6 weeks post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Note Errors (Related to Errors in Duration), Baseline Note Errors (Related to Errors in Duration), Post-injection
Hide Arm/Group Description:
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 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).
Overall Number of Participants Analyzed 16 16
Median (Standard Error)
Unit of Measure: msec
8.20  (8.49) 5.79  (4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Note Errors (Related to Errors in Duration), Baseline, Note Errors (Related to Errors in Duration), Post-injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Note Errors (Related to Errors in Loudness)
Hide Description 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.
Time Frame Baseline and 6 weeks post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Note Errors, Baseline Note Errors, Post-injection
Hide Arm/Group Description:
Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. 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 loudness.
Note errors (related to errors in loudness) 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).
Overall Number of Participants Analyzed 16 16
Median (Standard Error)
Unit of Measure: decibels
10.06  (1.28) 8.43  (1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Note Errors, Baseline, Note Errors, Post-injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Subjective Assessment Ratings of Change
Hide Description Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).
Time Frame Baseline to 6 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post-injection Subjective Change
Hide Arm/Group Description:
Subjective assessment 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).
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: percentage change
30  (29.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin, Type B
Hide Arm/Group Description 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.
All-Cause Mortality
Botulinum Toxin, Type B
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin, Type B
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botulinum Toxin, Type B
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Seth Pullman
Organization: Clinical Motor Physiology Laboratory
Phone: 212-305-3808
Responsible Party: Seth Pullman, Columbia University
ClinicalTrials.gov Identifier: NCT00208091     History of Changes
Other Study ID Numbers: AAAB2808
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: August 22, 2013
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014