Neurotoxin and Physical Therapy

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.

Conditions

• Cervical Dystonia

Interventions

DRUG

Botox injection

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

BEHAVIORAL

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.

PROCEDURE

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.

Sponsors & Collaborators

• American Academy of Neurology

  collaborator OTHER

• National Ataxia Foundation

  collaborator OTHER

• American Brain Foundation

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Aparna Wagle Shukla, MD · University of Florida

• Michael S Okun, MD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2017-01-07

Completion

2017-01-07

FDA Device

Yes

Countries

• United States

Study Locations