Neurotoxin and Physical Therapy

NCT ID: NCT02177617

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-01-07

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).

Conditions

Cervical Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Botox only

Participants randomized to receive Botox injections alone.

Group Type: ACTIVE_COMPARATOR

Botox injection

Intervention Type: DRUG

Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms

Transcranial magnetic stimulation (TMS)

Intervention Type: PROCEDURE

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.

Botox plus Physical Therapy

Participants randomized to receive Botox injection combined with Physical Therapy

Group Type: ACTIVE_COMPARATOR

Botox injection

Intervention Type: DRUG

Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms

Physical Therapy

Intervention Type: BEHAVIORAL

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)

Intervention Type: PROCEDURE

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.

Interventions

Botox injection

Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: PROCEDURE

Other Intervention Names

Neurotoxin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Neurology

OTHER

Sponsor Role: collaborator

National Ataxia Foundation

OTHER

Sponsor Role: collaborator

American Brain Foundation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aparna Wagle Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Michael S Okun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201400343

Identifier Type: -

Identifier Source: org_study_id