Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2022-08-20
2024-08-31
Brief Summary
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Regeneration of lost neurons with new ones (i.e., neurogenesis) is compromised at early stages of dementia and in part correlates with cognitive impairment in Alzheimer's disease. Boosting the neurogenesis delays the cognitive impairment in animal models of dementia and has been proven beneficial in improving the memory in rodent studies.
Aerobic exercise is the most potent known stimulator of neurogenesis in animal models. A crucial next step is to translate endogenous regenerative strategies to people. The purpose of this study is to demonstrate the feasibility and investigate the effects of an exercise program on neurogenesis and cognitive improvement in epilepsy patients.
Detailed Description
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Ten people with MTLE who are recommended for surgical treatment as part of their standard care will be enrolled and randomly assigned to High Impact (n=5) and Low Impact (n=5) exercise groups. The duration of exercise programs will be 12 weeks and study arms will undergo the same protocol except for the target heart rate which will be higher in the High-Impact group. Exercise will be performed at home using a recliner bike under the supervision of caregiver and study personnel. Participants will undergo cognitive, exercise and clinical assessment at baseline and after completing the three-month exercise therapy; then surgically resected tissue will be analyzed for regeneration and epileptiform activity. The investigators will assess whether exercise would yield clinical benefits in terms of seizure frequency/intensity or cognitive ability, and whether the ability of the adult human brain to self-repair can be enhanced. It is hypothesized that the proposed exercise regimen is feasible and will improve the neurogenesis levels and cognition.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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High-impact Exercise
High-Impact Aerobic Exercise
Participants will be submitted to a 12-week high-impact aerobic exercise program using a recliner bike with three sessions per week. The exercise protocol takes 45 minutes per session and consists of five minutes of warm-up, 30 minutes of cycling with progressive increase in intensity until the target heart rate (80% of maximum) is reached, followed by 10 minutes of cool down.
Low-impact Exercise
Low-Impact Aerobic Exercise
Participants will be submitted to a 12-week low-impact aerobic exercise program using a recliner bike with three sessions per week. The exercise protocol takes 45 minutes per session and consists of five minutes of warm-up, 30 minutes of cycling with progressive increase in intensity until the target heart rate (40% of maximum) is reached, followed by 10 minutes of cool down.
Interventions
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High-Impact Aerobic Exercise
Participants will be submitted to a 12-week high-impact aerobic exercise program using a recliner bike with three sessions per week. The exercise protocol takes 45 minutes per session and consists of five minutes of warm-up, 30 minutes of cycling with progressive increase in intensity until the target heart rate (80% of maximum) is reached, followed by 10 minutes of cool down.
Low-Impact Aerobic Exercise
Participants will be submitted to a 12-week low-impact aerobic exercise program using a recliner bike with three sessions per week. The exercise protocol takes 45 minutes per session and consists of five minutes of warm-up, 30 minutes of cycling with progressive increase in intensity until the target heart rate (40% of maximum) is reached, followed by 10 minutes of cool down.
Eligibility Criteria
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Inclusion Criteria
* Medically resistant mesial temporal lobe epilepsy
* Candidacy for standard or selective temporal lobectomy
Exclusion Criteria
* Pregnancy
* Physical disabilities or medical conditions preventing from participation in exercise program
* Inability to receive exercise equipment at home
* Cognitive/developmental disabilities restricting the participation in exercise program
18 Years
65 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Jonathan Russin
Assistant Professor of Clinical Neurological Surgery
Principal Investigators
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Jonathan J Russin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California Department of Neurosurgery
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Jonathan J Russin, MD
Role: primary
References
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Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol. 2017 Apr;81(4):479-484. doi: 10.1002/ana.24897. No abstract available.
Other Identifiers
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APP-21-04349
Identifier Type: -
Identifier Source: org_study_id