N/A N=20 Randomized Single-blind Diagnostic

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

Spasticity · Focal Dystonia · Tremor, Limb

Bottom Line

View on ClinicalTrials.gov: NCT02334683 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Nov 2021

Primary outcome: Primary: Change in Patient Global Impression of Change — 53.1; 51.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electrical stimulation (Device); Ultrasound (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient Global Impression of Change	53.1; 51.5	—
SECONDARY Change in Visual Analog Scale	54.72; 52.37	—
SECONDARY Change in Muscle Strength	29.89; 20.63	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02334683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.