Botulinum Toxin for Neurological Movement Disorders
This 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.
Data Collection
Collected from today forward - ProspectiveCentral Nervous System Diseases
+ Movement Disorders
+ Nervous System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 26, 1989
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
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
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps