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临床试验/NCT05179083
NCT05179083招募中1 期

Regenerating the Adult Human Brain Through Exercise

University of Southern California2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年8月20日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
10
试验地点
2
主要终点
Adherence to exercise and assessments

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Adherence to exercise and assessments

时间窗: Through study completion, an average of 6 months

Number of completed exercise and assessment sessions

次要结局

  • Rey Auditory Verbal Learning Test (RAVLT) - Summary score(Baseline and 12 weeks after first exercise session)
  • Neurogenesis(13 weeks after first exercise session)
  • Rey Auditory Verbal Learning Test (RAVLT) - Trial V(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Russin

Assistant Professor of Clinical Neurological Surgery

University of Southern California

研究点 (2)

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