RECRUITING

Botulinum Toxin for the Treatment of Involuntary Movement Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Botulinum Toxin for the Treatment of Neurological Disorders

Quick Facts

Study Start:1989-10-26
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00001208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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.
  1. 1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
  2. 2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
  3. 3. For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders

Contacts and Locations

Study Contact

Vivian S Koo
CONTACT
(301) 435-8518
vivian.koo@nih.gov
Debra J Ehrlich, M.D.
CONTACT
(301) 443-7888
debra.ehrlich@nih.gov

Principal Investigator

Debra J Ehrlich, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Debra J Ehrlich, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1989-10-26
Study Completion DateN/A

Study Record Updates

Study Start Date1989-10-26
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Botulinum Toxin
  • BTW
  • Natural History

Additional Relevant MeSH Terms

  • Movement Disorders