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Botulinum Toxin for Neurological Movement Disorders

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Study AimThis study observes people with dystonia and other movement disorders to collect data on their standard treatment and natural history, which will help inform future research.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Movement Disorders

From 2 to 100 Years
+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 1989

See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactVivian S Koo
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 26, 1989Actual date on which the first participant was enrolled.

This study explores the use of botulinum toxin (BTX) for treating neurological disorders that cause involuntary muscle spasms or movements. Botulinum toxin has been shown to be effective in managing these conditions, but treatment needs to be customized for each individual. The study targets patients with dystonia and other movement disorders, aiming to enhance understanding of how these disorders progress and how botulinum toxin can be used effectively. Insights from this study could improve treatments for individuals with these challenging conditions, potentially leading to better management and quality of life. Participants in the study receive standard botulinum toxin injections tailored to their specific needs. The study observes and records the natural progression of their movement disorders and their responses to the injections. By maintaining a group of patients receiving this treatment, researchers can gather valuable data, which may be used to address future research questions about the conditions and their treatment. There are no new interventions or experimental procedures involved, as the study focuses on observing and documenting existing treatment practices.

Official TitleBotulinum Toxin for the Treatment of Neurological Disorders 
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Study ContactVivian S Koo
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Movement Disorders
Criteria
3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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 Objectives
Primary Objectives

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.

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
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One Study Center