Overview

This trial is active, not recruiting.

Condition cervical dystonia
Treatments botox injection, physical therapy, transcranial magnetic stimulation (tms)
Phase phase 4
Sponsor University of Florida
Collaborator American Academy of Neurology
Start date December 2014
End date December 2016
Trial size 40 participants
Trial identifier NCT02177617, IRB201400343

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants randomized to receive Botox injections alone.
botox injection Neurotoxin
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
transcranial magnetic stimulation (tms)
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.
(Active Comparator)
Participants randomized to receive Botox injection combined with Physical Therapy
botox injection Neurotoxin
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
physical therapy
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.
transcranial magnetic stimulation (tms)
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.

Primary Outcomes

Measure
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
time frame: Change from Baseline to Week 12
Short Form 36 Health Survey (SF-36)
time frame: Change from Baseline to Week 12
Clinical Global Impression Scale (CGIS)
time frame: Change from Baseline to Week 12

Secondary Outcomes

Measure
Neuroplasticity Assessment
time frame: Change from Baseline to Week 12

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Synergistic Effects of Neurotoxin and Physical Therapy
Principal investigator Aparna Wagle Shukla, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Florida.