Investigating how exercise affects brain and movement in dystonia patients
Progressive Resistance Exercise and Dystonia Pathophysiology.
This study is testing if a structured exercise program can improve movement and brain function in people with focal cervical dystonia who haven't had much success with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05663840 on ClinicalTrials.gov |
What this trial studies
This research focuses on understanding the effects of progressive resistance exercise on individuals with focal cervical dystonia. The study will utilize functional MRI (fMRI) and transcranial magnetic stimulation (TMS) to assess brain adaptations and changes in motor behavior in response to a structured exercise program. Participants will be divided into two groups: one receiving exercise training alongside standard care and the other continuing standard care without exercise. The goal is to determine if exercise can enhance treatment outcomes for patients who have not responded well to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 85 with predominantly focal cervical dystonia and moderate disease severity who have not achieved optimal benefits from standard treatments.
Not a fit: Patients with significant cognitive impairment, those participating in other structured exercise programs, or those with contraindications for MRI or TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve symptoms in patients with dystonia who have not benefited from traditional treatments.
How similar studies have performed: While exercise has been explored in various movement disorders, this specific approach focusing on dystonia and utilizing advanced imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Aparna Wagle Shukla, MD — University of Florida
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.