Regenerating the Adult Human Brain Through Exercise
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Adherence to exercise and assessments
Study Overview
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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High-impact Exercise
Intervention: High-Impact Aerobic Exercise (Other)
Low-impact Exercise
Intervention: Low-Impact Aerobic Exercise (Other)
Outcomes
Primary Outcomes
Adherence to exercise and assessments
Time Frame: Through study completion, an average of 6 months
Number of completed exercise and assessment sessions
Secondary Outcomes
- 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)
- Neurogenesis(13 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)
Investigators
Jonathan Russin
Assistant Professor of Clinical Neurological Surgery
University of Southern California