Neurotoxin and Physical Therapy

University of Florida

Status and phase: Completed; Phase 4

Conditions: Cervical Dystonia

Treatments: Behavioral: Physical Therapy; Procedure: Transcranial magnetic stimulation (TMS); Drug: Botox injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02177617

IRB201400343

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Botox only

Active Comparator group

Description:

Participants randomized to receive Botox injections alone.

Treatment:

Drug: Botox injection

Procedure: Transcranial magnetic stimulation (TMS)

Botox plus Physical Therapy

Active Comparator group

Description:

Participants randomized to receive Botox injection combined with Physical Therapy

Treatment:

Drug: Botox injection

Procedure: Transcranial magnetic stimulation (TMS)

Behavioral: Physical Therapy