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Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
NCT06133283 · The University of Texas Health Science Center at San Antonio
In plain English
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Official title
High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
About this study
This study will enroll individuals diagnosed with Parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). Outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by H reflex) and quality of life.
Eligibility criteria
Inclusion Criteria:
1. Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
3. Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).
Exclusion Criteria:
1. Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
3. Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
4. Subjects with a history of head injury.
5. Subjects with a history of seizures or epilepsy.
6. Subjects who are currently pregnant.
7. Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
8. Individuals with skull abnormalities, fractures or unexplained, recurring headaches.
Study design
Enrollment target: 16 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-09
Estimated completion: 2026-12-31
Last updated: 2026-03-31
Interventions
Behavioral: High intensity endurance exerciseBehavioral: Stretching exerciseBehavioral: Virtual reality (VR)-based gaming
Primary outcomes
- • Balance (Baseline, post (8 week), follow-up (14 weeks))
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: National Center for Advancing Translational Sciences (NCATS)
Contacts & investigators
ContactAnjali Sivaramakrishnan, PhD · contact · sivaramakris@uthscsa.edu · 210-567-8626
InvestigatorAnjali Sivaramakrishnan · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (1)
UT Health San Antonio- Dept. of Physical TherapyRecruiting
San Antonio, Texas, United States