Phase 4
N=16
Neurotoxin and Physical Therapy
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT02177617 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) — 28; 20.1 total score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botox injection (Drug); Physical Therapy (Behavioral); Transcranial magnetic stimulation (TMS) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
28; 20.1 | — |
| PRIMARY SF-36 Physical Functioning Subscore |
68; 88 | — |
| PRIMARY Clinical Global Impression Scale (CGIS) |
3; 2 | — |
| SECONDARY Mean MEP After Paired Associative Stimulation (PASmean) |
1.7; 1.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02177617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.