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

Not Applicable

Completed

• Conditions: Focal Dystonia; Tremor, Limb; Spasticity
• Interventions: Device: Ultrasound; Device: Electrical stimulation

• Registration Number: NCT02334683
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 Timeline

• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-08
• Study Start: 2015-10-28
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Status Verified: 2021-10
• Results First Submitted: 2021-10-28
• Results First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Results First Posted: 2021-11-26
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ultrasound guidance	Ultrasound	Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.
Electrophysiologic guidance	Electrical stimulation	Electrophysiologic guidance, using electrical stimulation

Primary Outcome Measures

Name	Time	Method
Change in Patient Global Impression of Change	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.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale	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.
Change in Muscle Strength	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.

Trial Locations

Locations (2)

Ninds, Nih; 🇺🇸 Bethesda, Maryland, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States