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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spasticity, Focal Dystonia, Tremor, Limb

Intervention / Treatment
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* Device: Electrical stimulation
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrophysiologic guidance<br>Electrophysiologic guidance, using electrical stimulation | Device: Electrical stimulation<br>* 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.<br>* Other names: E-stim;|
| Active Comparator: Ultrasound guidance<br>Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles. | Device: Ultrasound<br>* 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.<br>* Other names: Sonography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Impression of Change | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparison, Botulinum toxin treatments, Ultrasound, Electrophysiologic, Spasticity, Focal dystonia