Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05663840

Effects of Exercise on Dystonia Pathophysiology

The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training.

Recruiting

Interested in participating?

Request Info

Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Aparna Wagle Shukla, MD

CONTACT

[email protected]

352-273-5550

Aparna Wagle Shukla, MD

PRINCIPAL_INVESTIGATOR

About this study

Dystonia is a debilitating movement disorder. It involves involuntary muscle contractions with abnormal and repetitive movements, postures, or both. The current treatments for dystonia comprise of oral medications, botulinum toxin injections, and deep brain stimulation surgery. These treatments, despite optimal management, fail to improve symptoms in more than a third of patients and the improvements are often unpredictable. We will investigate the brain adaptation effects for progressive resistance exercise-focused cervical and shoulder training (PERFECT) in patients with focal cervical dystonia with functional MRI (fMRI) and transcranial magnetic stimulation (TMS) techniques for understanding the pathophysiology of dystonia and treatment related changes. The investigators propose to enroll patients with predominantly focal cervical dystonia and compare PERFECT plus standard-of-care (SOC) therapy (n = 27) with a control group of SOC therapy (n = 27). Participants in the PERFECT + SOC group will perform physical therapist-guided exercises twice a week for 6 months and participants in the SOC group will continue receiving standard pharmacological therapies at stable doses and they will not exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society.
  • Moderate disease severity.
  • Are 30 to 85 years old
  • Are able to tolerate exercise sessions.
  • Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy.

Exclusion criteria

  • Participating in an alternate structured exercise program, receiving regular physical or occupational therapy
  • Have significant pain, spondylosis or active arthritis
  • Fail the Physical Activity Readiness Questionnaire
  • Have significant cognitive impairment
  • Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS
  • Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. As necessitated by the risks of MRI or TMS, patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), active seizure disorder are not eligible for participation in the MRI or TMS portion of the study.
  • Pregnancy tests will be carried out for each female subject of child bearing potential prior to the participation in the study and prior to each follow up visit (as indicated).

Treatment and study plan

Progressive resistance exercise

Behavioral

Patients with predominant symptoms of cervical dystonia will receive exercise training. Patients will receive progressive resistance exercise focused cervical and shoulder training (PERFECT) plus standard-of-care (SOC) therapy. Resistance training will consist of mainly muscle-strengthening exercises for the neck, shoulder and arms and a few upper trunk muscles. Resistance training will be guided by physical therapists at twice a week schedule for 6 months. These participants will also receive SOC therapy.

Standard of Care

Behavioral

Subjects will receive SOC therapy only

Primary outcomes

  1. Brain effects measured with fMRI

    Time frame: Baseline up to 6 months

    To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.

  2. Brain effects measured with TMS

    Time frame: Baseline up to 6 months

    To measure motor cortex excitability and plasticity in TMS findings.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Progressive Resistance Exercise and Dystonia Pathophysiology.

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.