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临床试验/NCT07509177
NCT07509177招募中不适用

Photobiomodulation Radiant Intervention for Stress in Epilepsy

Cynthia Kerson1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Subjective level of stress

研究概览

简要总结

Do you have Epilepsy? Would you like to participate in a study using PhotoBioModulation (PBM)? PBM is being researched for potential benefits in resolving many stress-related brain disorders. It is a non-invasive technique that delivers light energy to cells and tissues that can promote brain stabilization and self-regulation, cell repair, reduce oxidative stress, and enhance cellular function. We ask you to participate for about 3-4 months and come to our facility for 30 minute sessions 3x a week for 15 weeks. You will receive extensive metabolic testing and an Õura ring for your participation.

详细描述

WHO claims that epilepsy effects over 50 million people world-wide. First line treatment for seizures has been medication for well over 50 years with mixed results. There are many types of seizures, and the medications prescribed hope to target the type diagnosed, but while they may control the seizures to some effect, they also are riddled with side effects that create further duress. Other interventions may include surgery, vagal nerve stimulation (VNS) and other neurostimulation methodologies, diet and other lifestyle changes, and behavioral modification1. Comorbidities of epilepsy include anxiety, stroke, depression, ADHD, and possibly physical health compromises due to falling2. Stress often precipitates epileptic seizures, whether the syndrome is congenital, metabolic, electrophysiological, or environmental in nature3, 4.

Turner5 highlights a need for better interventions for this population, and the current proposal hopes to learn if photobiomodulation (PBM), a modern intervention which has shown promise in many syndromes, including anxiety, Parkinson's disease, pain and inflammation6 can reduce perceived stress, which in turns informs a healthier lifestyle for people with epilepsy (PWE) and reduce the effects of this disease. Since this intervention is quite new, few research projects have been published in this area.

Light is a fascinating phenomenon. Most people can identify color, and this is because of how it vibrates7. It's the vibration that causes us to feel warmed (yellows) or cooled (blues) since the speed of the vibration is stimulating neuronal communication. It's a brilliant innovation to use this property in photobiomodulation (PBM), which is the use of near-infra red light, as a clinical tool to enhance brain function on a cellular and chemical level. It is understood that what light therapy provides is a mitochondrial stimulatory mechanism that ultimately increases blood and cerebral spinal fluid (CSF) flow, cerebral oxygenation, and ATP production, as well as promote brain stabilization and self-regulation, and reduces inflammation8. It has been shown that the emitted light does, in fact, penetrate the skull and reach the desired cortical levels of the brain to facilitate the necessary mechanism to fulfill its goals9, 10.

The positive effects on mitochondrial health with PBM, and this interaction with epileptic brain behaviors11, as well as with neurodegenerative diseases12, 13, Parkinson's14, inflammation15, and TBI16 among others has been shown. In this study, we are primarily looking at if PBM can facilitate reduction of perceived stress in the PWE population. It is prudent to establish that we are not treating epilepsy because the device we're using is not FDA-cleared for brain-based procedures. However, current literature supports this, and present anecdotal evidence advises this intervention to be very successful and validates the proposed rigorous investigation.

The current study aims to use PBM to reduce stress in participants with epilepsy as a complementary therapeutic modality for improving quality of life and reducing suffering. PWE will be recruited to 4 clinical sites within the U.S. (Cincinnati, Houston, Miami, Warren, OH) and provided with PBM 3x/weekly for forty-five, 20-minute sessions, which may last between 15 and 20 weeks. They will have intake (T0), baseline (T1), mid (T2) post (T3) and 6-month follow-up (T4) assessment sessions in addition to the 45 PBM sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Statistical analyzer

入排标准

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

入选标准

  • • >18 YO
  • Epilepsy - medical diagnosis with at least one seizure within the past 6 months: diagnosis to be obtained from medical records from the treating physician by signature of HIPAA-compliant medical release form
  • Agreement to maintain or reduce medication regimen (based upon prescribers' advice)
  • Available for intake, baseline, post-treatment, 6-month follow-up assessments, and 45 sessions of PBM
  • Willingness to wear an Õura ring at all times (except for charging) for the duration of the study.
  • Substance use
  • Personality disorders
  • Heavy metal toxicity
  • Mold toxicity
  • Metabolic measures thresholded based on participant type
  • Increase in current medication (dosage and/or type)
  • No new medications prescribed (reduction as prescribed by prescribing physician OK)
  • Current brain bleed
  • Acute TBI within the last 12 months
  • History of neuromodulation, including ECT
  • Brain implants/pumps/shunts
  • History of brain surgery
  • Hormone replacement therapy for menopause or gender transition
  • Untreated sleep disorders

排除标准

  • 未提供

研究组 & 干预措施

Active photobiomodulation sessions

Active Comparator

Participants will undergo 45 20-minute sessions of photobiomodulation. All other aspects of the study will be the same as the sham group.

干预措施: Photobiomodulation (Other)

Control photobiomodulation sessions

Sham Comparator

One third of the participants will undergo 45 20-minute 'fake' photobiomodulation sessions. All other aspects of the study will be the same as the active group.

干预措施: Photobiomodulation (Other)

结局指标

主要结局

Subjective level of stress

时间窗: Start to post-intervention to 6-month follow-up

This study will look at how perceived stress can be moderated with 45 20-minute photobiomodulation sessions and how this affects seizure duration, intensity, and frequency in people with epilepsy, with the Perceived Stress Scale (PSS), and a post score 20% improved from the pre-test score.

次要结局

未报告次要终点

研究者

发起方
Cynthia Kerson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cynthia Kerson

Associate Professor, Principal Investigator

Saybrook University

研究点 (1)

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