Recruiting
Phase 1

Aerobic Exercise

Sponsor:

University of Southern California

Code:

NCT05179083

Conditions

Temporal Lobe Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

High-Impact Aerobic Exercise

Low-Impact Aerobic Exercise

Study Details

Brief summary:

Nearly 100 million Americans are affected by neurological disorders with an overall cost above $765 billion for the more prevalent conditions. Given this significant burden, effective treatments to prevent dementia and new disease modifying therapies are urgently needed.

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.

Conditions

Temporal Lobe Epilepsy

Study ID

NCT05179083

Start date

Aug 20, 2022

Status verified date

Dec, 2023

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age of 18 years or older
  • Medically resistant mesial temporal lobe epilepsy
  • Candidacy for standard or selective temporal lobectomy

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High-impact Exercise

active comparator: Low-impact Exercise

Interventions

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.

Primary outcome measure

  • Adherence to exercise and assessments [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Jonathan J Russin, MD

800-872-2273Jonathan.Russin@med.usc.edu

Locations

University of Southern California Department of Neurosurgery

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jonathan J Russin, MD

323-226-2271

More Information

Sponsor

University of Southern California

Last update posted

Dec 6, 2023

Last verified

Dec, 2023

Keywords

  • Exercise
  • Neurogenesis
  • Mesial temporal lobe epilepsy
  • Regeneration
  • Cognition
  • Electrophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-12-06.