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

NCT ID: NCT02334683

Last Updated: 2021-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2020-03-03

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.

Conditions

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Spasticity Focal Dystonia Tremor, Limb

Keywords

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Comparison Botulinum toxin treatments Ultrasound Electrophysiologic Spasticity Focal dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Electrophysiologic guidance

Electrophysiologic guidance, using electrical stimulation

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type DEVICE

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.

Ultrasound guidance

Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DEVICE

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.

Interventions

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Electrical stimulation

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.

Intervention Type DEVICE

Ultrasound

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.

Intervention Type DEVICE

Other Intervention Names

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E-stim Sonography

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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David M. Simpson

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Ninds, Nih

Bethesda, Maryland, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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#86127

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 14-1113

Identifier Type: -

Identifier Source: org_study_id

NCT02326818

Identifier Type: -

Identifier Source: nct_alias