NCT05663840 Effects of Exercise on Dystonia Pathophysiology
| NCT ID | NCT05663840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2022-10-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2022-10-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Aparna Wagle Shukla, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05663840 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 85 Years, studying Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05663840 currently recruiting?
Yes, NCT05663840 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Florida to inquire about joining.
Where is the NCT05663840 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05663840 clinical trial?
NCT05663840 is sponsored by University of Florida. The principal investigator is Aparna Wagle Shukla, MD at University of Florida. The trial plans to enroll 56 participants.