Botulinum Toxin for the Treatment of Involuntary Movement Disorders
2 other identifiers
observational
2,000
1 country
1
Brief Summary
BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response. The application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 1989
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedApril 29, 2026
March 23, 2026
November 3, 1999
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Study Natural History- data analysis
Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.
Ongoing
Maintain cohort of subjects
To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection
Ongoing
Study Arms (1)
Patients
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. 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.
Eligibility Criteria
Patients with a movement disorder will be enrolled.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
- Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
- For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra J Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
October 26, 1989
Last Updated
April 29, 2026
Record last verified: 2026-03-23
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared indefinitely.
- Access Criteria
- We do plan on broad data sharing. Therefore, there will be no restrictions on whom the data can be shared with.
All collected IPD stored in the database will be shared. @@@@@@@@@@@@We may share identifiable research data with other NIH protocols, when subjects are co-enrolled. Data can be shared with other protocols, investigators, and subject health care and medical team upon subject requests and permissions. Data that may be shared are demographics, diagnosis, botulinum toxin injections (including site, dose, localication technique), response to injections, assessments from clinical evaluations and clinical rating scales or test results that are conducted for each subject. Data that is shared may be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH. @@@@@@@@@@@@