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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0035

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Dystonia;
Botulinum Toxin;
Musician's Dystonia;
Spasticity

Recruitment Keyword(s)

None

Condition(s)

Dystonia;
Focal Dystonia;
Musician's Dystonia;
Muscle Spasticity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: BoNT injection
Procedure/Surgery: US guidance
Procedure/Surgery: E-stim Guidance

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D37
10 CENTER DR
BETHESDA MD 20814
(301) 496-9526
hallettm@ninds.nih.gov

Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02326818

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