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临床试验/NCT07642739
NCT07642739尚未招募不适用

Nature as Medicine for the Healing Brain: Utilization of a Nature-based Exposure Intervention for Decreasing Concussion Recovery Timeline and Symptom Load

Penn State University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1

研究概览

简要总结

The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of individuals suffering from concussion, and decrease their risk of developing Persistent Post-Concussion Syndrome (PPCS).

We hypothesize that successful adherence to a nature-based exposure therapy intervention program will decrease recovery time and severity of symptom trajectory of concussion, as measured through multimodal assessments of brain structural and functional integrity.

详细描述

This study will use a resting state combined electrophysiological-imaging measure of brain region activation, a blood-based measure of neuroinflammatory protein circulation, and a brief but comprehensive neuropsychological functional assessment to identify recovery status of the brain pre- and post-intervention. Measures will be taken at two pre-determined time intervals following concussion for each participant (1-3 days, 28-30 days) and frame the start and end point of a 4-week nature-based exposure therapy intervention program. The self-administered nature-based exposure therapy intervention will consist of 4 weeks of 120 minutes per week (spread over 3-7 days) of nature-based exposure coupled with a guided environmental awareness prompt list per week (Harries et al., 2025; Leão et al., 2025; White et al., 2019).

The primary aim of this study will be to assess the utility of a nature-based exposure therapy intervention in decreasing symptom severity and timeline of concussion. The intervention will include a multi-week program during which patients will participate in a specified duration of emersion in "nature-based environments". This intervention will inform a low-risk, holistic method for concussion management and may decrease risk of PPCS onset. A multimodal measurement battery will assess structural, functional, and behavioral concussion recovery factors as they relate to the nature-based intervention. Trends in recovery measures will be recorded at pre- and post-intervention, as well as throughout the intervention time period to assess both the feasibility/adherence and efficacy of nature-based exposure on recovery from concussion.

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
None

入排标准

年龄范围
14 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Require that any participant is 14-35 years old
  • Required that any participant under 18 years old can be accompanied by a parent or legal guardian for the duration of the study
  • Required that participants be English speakers
  • Required that persons be able to provide consent for themselves
  • Required that the participant must have suffered a clinically diagnoses concussion 5 days or less prior to the first study visit
  • Concussion must have been diagnosed by a licensed clinical medicine professional.
  • No additional professional treatment modalities outside of normal clinical concussion recovery recommendations may have been received prior to study participation. These include participation in a separate concussion rehabilitation study, cognitive behavioral therapies, vestibule-ocular therapies (balance), in-patient physical therapy, consumption of stimulant medication, and chiropractic manipulation.
  • Injury must have been diagnosed as a concussion or mild-traumatic brain injury. Participant must not have been diagnosed with of severe traumatic brain injury, hematoma, fractured skull or facial bones, or comatose.

排除标准

  • Exclude persons under 14 years old or over 35 years old
  • Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1
  • Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)
  • Those with presence of an active infection (including a dental infection)
  • Exclude persons who have migraines
  • Exclude persons taking mood stabilizer medications
  • Exclude persons who have consumed alcohol within 48 hours prior to study participation, participants will be asked this by one of the study members through the exclusion criteria screening form when they first contact the study
  • Exclude persons who are pregnant.

研究者

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

Owen Griffith

Assistant Teaching Professor

Penn State University

研究点 (1)

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