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

October 28, 2021 updated by: David M. Simpson, Icahn School of Medicine at Mount Sinai

Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Ninds, Nih
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrophysiologic guidance
Electrophysiologic guidance, using electrical stimulation
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 Names:
  • E-stim
Active Comparator: Ultrasound guidance
Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.
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 Names:
  • Sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Full scale from 0 = no improvement and 100 normal use. Higher score indicates better health outcome.
4 weeks and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Full scale from 0 = no improvement to 100 = normal. Higher score indicates more improvement.
4 weeks and 16 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.

Full scale 0 = no weakness and 100 is unable to move. Higher score indicates poorer health outcome.
4 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2015

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

December 24, 2014

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-1113
  • #86127 (Other Identifier: Allergan Pharmaceuticals Funding Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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