Clinical trial Recruiting at 1 site Observational Ages 2 to 100

Using botulinum toxin to treat involuntary movement disorders

Official title: Botulinum Toxin for the Treatment of Neurological Disorders

Run by National Institutes of Health Clinical Center (CC) · NCT00001208 · Data updated 2026-11-12

This study tests whether botulinum toxin can help people with involuntary movement disorders by customizing the treatment for each patient and using special techniques to give the injections.

Quick facts

Study typeObservational
Ages2 Years to 100 Years
SexAll
Enrollment2000 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedOctober 26, 1989
Registry record updatedNovember 9, 2026
Trial IDNCT00001208 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 2 years and older with movement disorders such as dystonia, hemifacial spasm, and spasticity that may respond to BTX treatment.

Probably not a fit

Patients who are pregnant, breastfeeding, or require certain antibiotics may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy of botulinum toxin (BTX) for treating various movement disorders characterized by involuntary muscle spasms. It focuses on tailoring BTX treatment to individual patients and employing specific injection techniques, including EMG and ultrasound guidance. The protocol allows for the observation of patients receiving standard BTX injections, contributing to a better understanding of the natural history of their conditions and their responses to treatment. Additionally, it serves as a training platform for physicians in the administration of BTX.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of movement disorders and enhance the quality of life for affected patients.

How similar studies have gone: Previous studies have demonstrated the efficacy of botulinum toxin for various movement disorders, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

  1. Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.
  2. Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.

EXCLUSION CRITERIA:

1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
3. For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Debra J Ehrlich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
  • Study coordinator: Vivian S Koo
  • Email: vivian.koo@nih.gov
  • Phone: (301) 435-8518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.