Clinical trial NCT00001208: Botulinum Toxin for the Treatment of Involuntary Movement Disorders
Official title: Botulinum Toxin for the Treatment of Neurological Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Movement Disorders
Keywords: Botulinum Toxin
BTW
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a movement disorder will be enrolled.

Brief summary: 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.

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 NIH studies.

Eligibility 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

Primary outcomes:
measure: Study Natural History- data analysis
timeFrame: Ongoing
measure: Maintain cohort of subjects
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Debra J Ehrlich, M.D.
role: PRINCIPAL_INVESTIGATOR
References: