Effectiveness of Myobloc in Treating Dystonia in Musicians

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Solstice Neurosciences
Information provided by (Responsible Party):
Seth Pullman, Columbia University
ClinicalTrials.gov Identifier:
NCT00208091
First received: September 13, 2005
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

This study uses a computerized method to quantify musical performance with music notation analysis 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 quantify any improvements or changes in performance following treatment.


Condition Intervention Phase
Focal Dystonia
Drug: Botulinum toxin, type B
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Computerized Quantitative Open Label Evaluation of the Efficacy of Myobloc in the Treatment of Focal Dystonia in Musicians

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pitch [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
  • Note speed [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
  • Fatigability [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
  • Timing [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
  • Tonal deterioration [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
  • Loudness/force [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective assessment of improvement by patient on scale of 0-100% [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: April 2003
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 69 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208091

Locations
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
Principal Investigator: Seth Pullman, MD Columbia University Medical Center, Department of Neurology
  More Information

No publications provided

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
Study First Received: September 13, 2005
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Myloboc
Botulinum Toxin Type B
Focal Dystonia
Musicians
Muscle Relaxtants
Motor Impairments
Motor Performance
Tremor
Abnormal Postures

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014