An observational study in Movement Disorders, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 2 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
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.
The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscle spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other NIH studies.
371 studies on the registry are indexed under Movement Disorders; 102 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 67 across 140 observational studies indexed under Movement Disorders.
Browse Movement Disorders studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 9, 2026. See what changed
Patients with a movement disorder will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
EXCLUSION CRITERIA:
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.
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.
Time frame: 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
Time frame: Ongoing
Plan to share: Yes — 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. @@@@@@@@@@@@
Supporting information: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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National Institute of Neurological Disorders and Stroke (NINDS) →