CompletedPhase 4

Neurotoxin and Physical Therapy

United States16 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

Timeframe: absolute value at Week 12

SF-36 Physical Functioning Subscore

Timeframe: absolute value at Week 12

Clinical Global Impression Scale (CGIS)

Timeframe: absolute value at Week 12

Trial details

NCT IDNCT02177617

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-07

Results submitted2022-04-20

View on ClinicalTrials.gov More Cervical Dystonia trials