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Clinical Trial NCT05179083 for Temporal Lobe Epilepsy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
University of Southern CaliforniaExercise for Brain Regeneration in Epilepsy
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.
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.
Regenerating the Adult Human Brain Through Exercise
- APP-21-04349
Neurogenesis
Mesial temporal lobe epilepsy
Regeneration
Cognition
Electrophysiology
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHigh-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. |
Active ComparatorLow-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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adherence to exercise and assessments | Number of completed exercise and assessment sessions | Through study completion, an average of 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Neurogenesis | Number of new neurons per mm3 in surgically resected tissue after cell culture | 13 weeks after first exercise session |
Rey Auditory Verbal Learning Test (RAVLT) - Trial V | The Rey Auditory Verbal Learning Test (RAVLT) is a validated test evaluating verbal learning and memory. In this test, lists of words are read to the participants in consecutive trials. Trial V is the 5th attempt at recalling the first list of words. | Baseline and 12 weeks after first exercise session |
Rey Auditory Verbal Learning Test (RAVLT) - Summary score | The Rey Auditory Verbal Learning Test (RAVLT) is a validated test evaluating verbal learning and memory. In this test, lists of words are read to the participants in consecutive trials. Summary score is the sum of number of words learned over five learning trials. | Baseline and 12 weeks after first exercise session |
WAIS-IV - Matrix Reasoning | Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) is a validated test of cognitive ability and intelligence. Matrix reasoning is among the tasks included in WAIS-IV which is used to assess non-verbal abstract problem solving and inductive reasoning. | Baseline and 12 weeks after first exercise session |
Rey Complex Figure Test (RCFT) | Rey Complex Figure Test (RCFT) is a standardized test of visuospatial memory. Performance will be scored based on the delayed recall trial of the RCFT. | Baseline and 12 weeks after first exercise session |
- Age of 18 years or older
- Medically resistant mesial temporal lobe epilepsy
- Candidacy for standard or selective temporal lobectomy
- Age of older than 65 years
- 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
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