Exercise for Brain Regeneration in Epilepsy

NCT05179083 | Unknown Phase 1

• 1 other identifier: APP-21-04349
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adherence to exercise and assessments

  Number of completed exercise and assessment sessions

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• Neurogenesis

  13 weeks after first exercise session

• Rey Auditory Verbal Learning Test (RAVLT) - Trial V

  Baseline and 12 weeks after first exercise session

• Rey Auditory Verbal Learning Test (RAVLT) - Summary score

  Baseline and 12 weeks after first exercise session

• WAIS-IV - Matrix Reasoning

  Baseline and 12 weeks after first exercise session

• Rey Complex Figure Test (RCFT)

  Baseline and 12 weeks after first exercise session

Study Arms (2)

High-impact Exercise

EXPERIMENTAL

Other: High-Impact Aerobic Exercise

Low-impact Exercise

ACTIVE COMPARATOR

Other: Low-Impact Aerobic Exercise

Interventions

High-Impact Aerobic Exercise OTHER

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.

High-impact Exercise

Low-Impact Aerobic Exercise OTHER

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.

Low-impact Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California Department of Neurosurgery

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 28198092 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe; Motor Activity

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Behavior

Study Officials

• Jonathan J Russin, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan J Russin, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurological Surgery

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 5, 2022
• Study Start: August 20, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)