Clinical trial NCT02177617: Neurotoxin and Physical Therapy
Official title: Synergistic Effects of Neurotoxin and Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Dystonia
Keywords: Cervical Dystonia
Botox
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Academy of Neurology
name: National Ataxia Foundation
name: American Brain Foundation
First posted: 2014-06-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will recruit primary cervical dystonia patients (age 18-80) who are stable on Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical Botox injection alone, or with physical therapy.

At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS) will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded movement disorder specialists. A pain scale will also be completed and range of head motion will be measured using a device similar to a protractor (called a goniometer). An individualized Botox injection will be administered, as well as transcranial magnetic stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new connections. If randomized to receive physical therapy, participants will also receive instructions to perform physical therapy exercises five times per week by a physical therapist who specializes in movement disorders. The investigator will call weekly to check how the participant is doing with the exercise program.

The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12 weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).

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

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: absolute value at Week 12
measure: SF-36 Physical Functioning Subscore
timeFrame: absolute value at Week 12
measure: Clinical Global Impression Scale (CGIS)
timeFrame: absolute value at Week 12
Secondary outcomes:
measure: Mean MEP After Paired Associative Stimulation (PASmean)
timeFrame: absolute value at week 12
Other outcomes:
measure: Visual Analog Scale
timeFrame: absolute value at 12 weeks
measure: Cervical Range of Motion Measurement
timeFrame: absolute value at 12 weeks was calculated
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Aparna Wagle Shukla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Michael S Okun, MD
role: PRINCIPAL_INVESTIGATOR
References: