Using botulinum toxin to treat involuntary movement disorders
Botulinum Toxin for the Treatment of Neurological Disorders
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 type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 2 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00001208 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or require certain antibiotics may not benefit from this study.
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 performed: Previous studies have demonstrated the efficacy of botulinum toxin for various movement disorders, indicating a promising approach.
Eligibility criteria
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, spasmodic dysphonia, 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.