Effects of Exercise on Dystonia Pathophysiology

NCT05663840 | Recruiting

• 2 other identifiers: IRB2022004901R01NS122943
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (2)

• Brain effects measured with fMRI

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

  Baseline up to 6 months

• Brain effects measured with TMS

  To measure motor cortex excitability and plasticity in TMS findings.

  Baseline up to 6 months

Study Arms (2)

Progressive resistance exercise (exercise group)

EXPERIMENTAL

Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group)

Behavioral: Progressive resistance exercise

Standard of care (non-exercise group).

ACTIVE COMPARATOR

Subjects will receive continuation of standard of care (non-exercise group).

Behavioral: Standard of care

Interventions

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.

Progressive resistance exercise (exercise group)

Standard of care BEHAVIORAL

Subjects will receive SOC therapy only

Standard of care (non-exercise group).

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Dystonia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Aparna Wagle Shukla, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: December 23, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)