Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Dystonia Clinical Trial

Official title:

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326818
• Other study ID #: 150035
• Secondary ID: 15-N-0035
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2016
• Est. completion date: March 26, 2020

Study information

• Verified date: December 16, 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

• It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable.

Objective:

• To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity.

Eligibility:

• Adults 18 and older with focal hand dystonia or arm spasticity who have been getting onabotulinumtoxin-A injections in protocol 85-N-0195.

Design:

• Participants will be screened with medical history and physical exam.

• Participants will push or pull on a device that measures arm strength. They will have a neurologic exam. Women will have a pregnancy test.

• Participants will have a BoNT injection using either e-stim or ultrasound.

• For e-stim, sticky pads will be placed on the arm. A needle will be placed in the muscle. A small electric shock will be given through the needle. Then the injection will be given.

• For ultrasound, a probe will be moved across the skin. A screen will show an image of the muscles. Then the injection will be given.

• Participants will have a second injection 3 months later. They will have the method that was not used for their first injection.

• After each session, participants will rate their experience.

• Participants will have follow-up visits 1 month after each injection. They will be examined and asked about their response to treatment. Arm strength will be measured.

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 upper limb onabotulinumtoxin 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 onaBoNT 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 to capture safety data. Visit 3 will be at week 12 when subjects will cross over and have the opposite treatment technique during their onaBoNT injection. Visit 4 will occur at week 16 as the final assessment where subjects will have measurements of efficacy and strength and to capture safety data by the blinded evaluator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• INCLUSION CRITERIA:

• Confirmed diagnosis of focal hand dystonia (FHD) or upper limb spasticity

• Stable onabotulinumtoxinA regimen and response for at least 2 treatment sessions, defined as no more than 15% difference in response on a visual analogue scale, with identical muscles targeted and dose at each session.

• Receiving botulinum toxin injections under 85-N-0195

• Age 18 and above

EXCLUSION CRITERIA:

• Contraindications to botulinum toxin such as a concomitant neuromuscular disorder or neuromuscular junction disorder

• Pregnancy or nursing

• Cognitive impairment and/or capacity impairment preventing reliable outcome measures self-report.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Focal Dystonia
• Muscle Spasticity
• Musician's Dystonia

Intervention

Procedure:
• US guidance
US guidance during injection of their stable, effective BoNT regimen
• E-stim Guidance
Electrophysiologic guidance via electrical stimulation during injection of their stable, effective BoNT regimen

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in dystonia or spasticity severity	Improvement in dystonia or spasticity severity on visual analogue scale	throughout

External Links

•   NIH Clinical Center Detailed Web Page