Exercise for Brain Regeneration in Epilepsy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Neurogenesis studies in healthy and dementia patients have only been performed on postmortem tissue, which prevents investigation of treatment outcomes. Patients with mesial temporal lobe epilepsy (MTLE) typically do not respond to medications and uniquely among related dementia disorders undergo corrective surgical treatment, providing a unique opportunity to study the value of regenerative interventions on hippocampal electrophysiology and neurogenesis. Using this unique approach, this study will investigate the 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05179083
Study type	Interventional
Source	University of Southern California
Contact	Jonathan J Russin, MD
Phone	800-872-2273
Email	Jonathan.Russin@med.usc.edu
Status	Recruiting
Phase	Phase 1
Start date	August 20, 2022
Completion date	August 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06269822` - Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP
Completed	`NCT05159609` - Closed Loop Auditory Stimulus in Sleep and epilepsY	N/A
Completed	`NCT02946151` - Subcutaneous EEG in Epilepsy	N/A
Not yet recruiting	`NCT02590419` - Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery	N/A
Completed	`NCT00595699` - Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy	Phase 4
Recruiting	`NCT06466681` - Changes in Attentional Control After a Focal Seizure.
Recruiting	`NCT05609084` - Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy	N/A
Completed	`NCT00344877` - Electrical Brain Stimulation to Reduce Epileptic Seizures	N/A
Not yet recruiting	`NCT05794295` - Sleep Architecture & Intrinsic Oscillatory and Network Connectivity in Cognition and Executive Dysfunction in TLE	N/A
Recruiting	`NCT03643471` - Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy
Terminated	`NCT00717431` - A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy	Phase 3
Completed	`NCT02844465` - Stereotactic Laser Ablation for Temporal Lobe Epilepsy	N/A
Recruiting	`NCT05019404` - Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.