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Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

This study is currently recruiting participants.
Verified May 31, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02326818
First Posted: December 30, 2014
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
  Purpose

Background:

- It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable.

Objective:

- To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity.

Eligibility:

- Adults 18 and older with focal hand dystonia or arm spasticity who have been getting onabotulinumtoxin-A injections in protocol 85-N-0195.

Design:

  • Participants will be screened with medical history and physical exam.
  • Participants will push or pull on a device that measures arm strength. They will have a neurologic exam. Women will have a pregnancy test.
  • Participants will have a BoNT injection using either e-stim or ultrasound.
  • For e-stim, sticky pads will be placed on the arm. A needle will be placed in the muscle. A small electric shock will be given through the needle. Then the injection will be given.
  • For ultrasound, a probe will be moved across the skin. A screen will show an image of the muscles. Then the injection will be given.
  • Participants will have a second injection 3 months later. They will have the method that was not used for their first injection.
  • After each session, participants will rate their experience.
  • Participants will have follow-up visits 1 month after each injection. They will be examined and asked about their response to treatment. Arm strength will be measured.

Condition Intervention Phase
Dystonia Focal Dystonia Musician's Dystonia Muscle Spasticity Procedure: BoNT injection Procedure: US guidance Procedure: E-stim Guidance Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):

Primary Outcome Measures:
  • Duration of BoNT injection procedure [ Time Frame: Months 0 and 3 ]
  • Patient discomfort on VAS [ Time Frame: Months 0 and 3 ]

Secondary Outcome Measures:
  • Modified Ashworth scale(spasticity) [ Time Frame: Months 0, 1, 3 and 4 ]
  • Arm Dystonia disability scale(dystonia) [ Time Frame: Months 0,1,3 and 4 ]
  • Physician global impression of change [ Time Frame: Months 1 and 4 ]
  • Improvement in dystonia or spasticity [ Time Frame: Months 1 and 4 ]
  • Self-reported satisfaction [ Time Frame: Months 1 and 4 ]
  • Number of needle sticks [ Time Frame: Months 0 and 3 ]
  • Side effect incidence [ Time Frame: Throughout ]
  • Muscle weakness [ Time Frame: Months 1 and 4 ]

Estimated Enrollment: 30
Study Start Date: December 24, 2014
Estimated Study Completion Date: July 31, 2019
Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 Stim-US
Patientes randomized to first E-stim then US guidance
Procedure: BoNT injection Procedure: US guidance Procedure: E-stim Guidance
Experimental: 3 US-Stim
Patients randomized to first US then E-stim guidance
Procedure: BoNT injection Procedure: US guidance Procedure: E-stim Guidance
Experimental: 1 US-Stim
Patients randomized to US guidance first
Procedure: BoNT injection Procedure: US guidance Procedure: E-stim Guidance
Experimental: 2 Stim-US
Patients randomized to E-stim first
Procedure: BoNT injection Procedure: US guidance Procedure: E-stim Guidance

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 upper limb onabotulinumtoxin 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 onaBoNT 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 to capture safety data. Visit 3 will be at week 12 when subjects will cross over and have the opposite treatment technique during their onaBoNT injection. Visit 4 will occur at week 16 as the final assessment where subjects will have measurements of efficacy and strength and to capture safety data by the blinded evaluator.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Confirmed diagnosis of focal hand dystonia (FHD) or upper limb spasticity
  • Stable onabotulinumtoxinA regimen and response for at least 2 treatment sessions, defined as no more than 15% difference in response on a visual analogue scale, with identical muscles targeted and dose at each session.
  • Receiving botulinum toxin injections under 85-N-0195
  • Age 18 and above

EXCLUSION CRITERIA:

  • Contraindications to botulinum toxin such as a concomitant neuromuscular disorder or neuromuscular junction disorder
  • Pregnancy or nursing
  • Cognitive impairment and/or capacity impairment preventing reliable outcome measures self-report.
  Contacts and Locations
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): NCT02326818


Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
United States, New York
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029-0574
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02326818     History of Changes
Other Study ID Numbers: 150035
15-N-0035
First Submitted: December 24, 2014
First Posted: December 30, 2014
Last Update Posted: October 19, 2017
Last Verified: May 31, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Dystonia
Botulinum Toxin
Musician's Dystonia
Spasticity

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