Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 8/11/2018 |
| Start Date: | December 24, 2014 |
| End Date: | July 31, 2019 |
| Contact: | Elaine P Considine, R.N. |
| Email: | considinee@ninds.nih.gov |
| Phone: | (301) 435-8518 |
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.
- 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.
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.
- 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.
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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