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Trial record 3 of 5 for:    focused ultrasound | Dystonia

Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia

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ClinicalTrials.gov Identifier: NCT02334683
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David M. Simpson, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE December 24, 2014
First Posted Date  ICMJE January 8, 2015
Last Update Posted Date November 27, 2019
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
Change in Patient Global Impression of Change [ Time Frame: 4 weeks and 16 weeks ]
clinical or patient self-rating form for grading evaluation of the treatment at 16 weeks as compared to at 4 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02334683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • Change in Visual Analog scale [ Time Frame: 4 weeks and 16 weeks ]
    patient perception of satisfaction and comfort at 16 weeks as compared to at 4 weeks.
  • Change in muscle strength [ Time Frame: 4 weeks and 16 weeks ]
    Muscle strength measured by dynamometry at 16 weeks as compared to at 4 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
Official Title  ICMJE Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity
Brief Summary This study seeks to compare the use of ultrasound and electrophysiologic techniques to target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity. Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard ways of locating muscles during a treatment of BoNT injection.
Detailed Description This is a study to investigate the use of two targeting techniques for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity: Electrophysiologic guidance, using electrical stimulation, and ultrasound. Subjects will be selected from the clinical programs of both Icahn School of Medicine at Mount Sinai and the National Institutes of Health who are already receiving onabotulinum toxin A injections clinically. The study will consist of four visits. Visit one consists of screening subjects who will then be consented and randomized to one of the two treatment techniques for their ona-BoNT injection: 1) Electrophysiologic guidance using electrical stimulation or 2) ultrasound. Visit 2 will occur at week 4 where the subjects will return for a follow up visit to have blinded evaluator measurements of efficacy and strength and capture safety data. Visit 3 will be at week 12 when subjects will cross over and have the alternate treatment technique during their ona-BoNT injection. Visit 4 will occur at week 16 as the final assessment where subjects will have measurements of efficacy and strength and capture safety data by the blinded evaluator.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Spasticity
  • Focal Dystonia
  • Tremor, Limb
Intervention  ICMJE
  • Device: Electrical stimulation
    The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves.
    Other Name: E-stim
  • Device: Ultrasound
    The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves.
    Other Name: Sonography
Study Arms  ICMJE
  • Experimental: Electrophysiologic guidance
    Electrophysiologic guidance, using electrical stimulation
    Intervention: Device: Electrical stimulation
  • Active Comparator: Ultrasound guidance
    Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.
    Intervention: Device: Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Confirmed diagnosis of focal upper extremity dystonia (FHD) or upper limb spasticity
  • Stable onabotulinumtoxinA dose regimen with a stable response as judged by the physician and patient for at least 2 treatment sessions.

Exclusion Criteria:

  • Contraindications to botulinum toxin
  • Pregnancy or nursing
  • Cognitive impairment that prevents reliable outcome measures of self-report
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Simpson, MD 212-241-8748 david.simpson@mssm.edu
Contact: Steven Frucht, MD 212-241-5607 steven.frucht@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02334683
Other Study ID Numbers  ICMJE GCO 14-1113
#86127 ( Other Identifier: Allergan Pharmaceuticals Funding Agency )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M. Simpson, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: David Simpson, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP