Neurotoxin and Physical Therapy
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

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).
    

Intervention name(s): Botox injection; Physical Therapy; Transcranial magnetic stimulation (TMS)
Intervention type(s): Drug; Behavioral; Procedure
Intervention description(s): Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms; Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.; For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.
Other intervention name(s): Neurotoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical Dystonia; Botox