Neurotoxin and Physical Therapy

• Status: Completed
• Trial end date: 2017-01-07
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: American Academy of Neurology; American Brain Foundation; National Ataxia Foundation
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a movement disorders specialist

• Positive response to at least two prior treatments with Botox as indicated by an improvement in Clinical Global Improvement Scale.

• Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

Exclusion Criteria:

• Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)

• Any secondary, fixed, post-traumatic, or psychogenic dystonia