Botulinum Toxin for the Treatment of Involuntary Movement Disorders

Botulinum Toxin for the Treatment of Neurological Disorders

Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such as stuttering and problems with the muscles of the eyes.

The study examines the effectiveness of botulinum toxin as treatment for a variety of movement disorders. The goals of the study are to refine the technique of treatment to provide the best results, to improve the understanding of how botulinum toxin works on movement disorders, and find other conditions that may be treatable with botulinum toxin.

In addition, researchers also plan to study the possible use of botulinum toxin F alone and in combination with botulinum toxin A in patients who do not respond to botulinum A toxin treatment.<TAB>

Study Overview

• Status: Recruiting
• Conditions: Movement Disorders

Detailed Description

The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles 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 studies on the physiology of sensorimotor systems and on the physiological effects of botulinum toxin.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Debra J Ehrlich, M.D.; Phone Number: (301) 443-7888; Email: debra.ehrlich@nih.gov
• Study Contact Backup: Name: Vivian S Koo; Phone Number: (301) 435-8518; Email: vivian.koo@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary clinical- Patients are evaluated for treatment with BTX in the movement disorders clinic of the Human Motor Control Section or by the Voice and Speech section, NINDS.

Description

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; Patients will be eligible for participation if they have a movement disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Debra J Ehrlich, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 1989

Study Registration Dates

• First Submitted: November 3, 1999
• First Submitted That Met QC Criteria: November 3, 1999
• First Posted (Estimated): November 4, 1999

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: February 7, 2024

More Information

Terms related to this study

• Keywords: Natural History; Botulinum Toxin; BTW
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: 850195; 85-N-0195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .Since this protocol is primarily a screening protocol, it may not be feasible to make data available on an individual patient level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No