ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT02326818
Recruitment Status : Recruiting
First Posted : December 30, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

December 24, 2014
December 30, 2014
August 9, 2018
December 24, 2014
July 31, 2019   (Final data collection date for primary outcome measure)
  • Duration of BoNT injection procedure [ Time Frame: Months 0 and 3 ]
  • Patient discomfort on VAS [ Time Frame: Months 0 and 3 ]
Same as current
Complete list of historical versions of study NCT02326818 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity
Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dystonia
  • Focal Dystonia
  • Musician's Dystonia
  • Muscle Spasticity
  • Procedure: BoNT injection
  • Procedure: US guidance
  • Procedure: E-stim Guidance
  • Experimental: 4 Stim-US
    Patientes randomized to first E-stim then US guidance
    Interventions:
    • Procedure: BoNT injection
    • Procedure: US guidance
    • Procedure: E-stim Guidance
  • Experimental: 3 US-Stim
    Patients randomized to first US then E-stim guidance
    Interventions:
    • Procedure: BoNT injection
    • Procedure: US guidance
    • Procedure: E-stim Guidance
  • Experimental: 1 US-Stim
    Patients randomized to US guidance first
    Interventions:
    • Procedure: BoNT injection
    • Procedure: US guidance
    • Procedure: E-stim Guidance
  • Experimental: 2 Stim-US
    Patients randomized to E-stim first
    Interventions:
    • Procedure: BoNT injection
    • Procedure: US guidance
    • Procedure: E-stim Guidance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
July 31, 2019
July 31, 2019   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
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
United States
 
 
NCT02326818
150035
15-N-0035
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
July 23, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP