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

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ClinicalTrials.gov Identifier: NCT02334683
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David M. Simpson, 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.

Condition or disease Intervention/treatment Phase
Spasticity Focal Dystonia Tremor, Limb Device: Electrical stimulation Device: Ultrasound Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity
Study Start Date : December 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia Ultrasound

Arm Intervention/treatment
Experimental: Electrophysiologic guidance
Electrophysiologic guidance, using electrical stimulation
Device: 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.
Other Name: E-stim

Active Comparator: Ultrasound guidance
Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.
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.
Other Name: Sonography




Primary Outcome Measures :
  1. Change in Patient Global Impression of Change [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in Visual Analog scale [ Time Frame: 4 weeks and 16 weeks ]
    patient perception of satisfaction and comfort at 16 weeks as compared to at 4 weeks.

  2. Change in muscle strength [ Time Frame: 4 weeks and 16 weeks ]
    Muscle strength measured by dynamometry at 16 weeks as compared to at 4 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334683


Contacts
Contact: David Simpson, MD 212-241-8748 david.simpson@mssm.edu
Contact: Steven Frucht, MD 212-241-5607 steven.frucht@mssm.edu

Locations
United States, Maryland
Ninds, Nih Recruiting
Bethesda, Maryland, United States, 20892
Contact: Codrin Lungu, MD    301-402-0976    lunguci@ninds.nih.gov   
Principal Investigator: Condrin Lungu, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Mary Catherine George    212-241-0784    mary-catherine.george@mssm.edu   
Principal Investigator: David Simpson, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Allergan
Investigators
Principal Investigator: David Simpson, MD Icahn School of Medicine at Mount Sinai

Responsible Party: David M. Simpson, Professor of Neurology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02334683     History of Changes
Other Study ID Numbers: GCO 14-1113
#86127 ( Other Identifier: Allergan Pharmaceuticals Funding Agency )
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by David M. Simpson, Icahn School of Medicine at Mount Sinai:
Comparison
Botulinum toxin treatments
Ultrasound
Electrophysiologic
Spasticity
Focal dystonia

Additional relevant MeSH terms:
Muscle Spasticity
Dystonia
Dystonic Disorders
Tremor
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs