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

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.

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