このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年6月9日 更新者:Owen Griffith、Penn State University

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

24

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Owen Griffith, PhD
  • 電話番号:15709858794
  • メール:omg5007@psu.edu

研究場所

    • Pennsylvania
      • University Park、Pennsylvania、アメリカ、16802
        • Recreation Building
        • コンタクト:
        • 主任研究者:
          • Owen Griffith, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Require that any participant is 14-35 years old
  2. Required that any participant under 18 years old can be accompanied by a parent or legal guardian for the duration of the study
  3. Required that participants be English speakers
  4. Required that persons be able to provide consent for themselves
  5. Required that the participant must have suffered a clinically diagnoses concussion 5 days or less prior to the first study visit
  6. Concussion must have been diagnosed by a licensed clinical medicine professional.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Exclude persons under 14 years old or over 35 years old
  2. Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1
  3. Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)
  4. Those with presence of an active infection (including a dental infection)
  5. Exclude persons who have migraines
  6. Exclude persons taking mood stabilizer medications
  7. 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
  8. Exclude persons who are pregnant.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Nature-based Guided Awareness Group
Participants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week.
Participants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week.
実験的:Standard Guided Awareness Group
Participants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week.
Participants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week.
介入なし:No Intervention Group
The No Intervention Group will proceed with their standard clinical care instructions for concussion recovery as provided by their health care professional.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Concussion Symptoms Scales
時間枠:Daily, for the duration of the 28 day study
All participants will complete daily Post-Concussion Symptom Scale surveys, offering self-report quantifiable measures of concussion recovery.
Daily, for the duration of the 28 day study

二次結果の測定

結果測定
メジャーの説明
時間枠
Stroop Task
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuropsychological test of processing speed and inhibition
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Oral Digit Symbol Modalities Task
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuropsychological measure of attention and memory
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Beck's Depression Inventory
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Depression symptom questionnaire
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Hamilton Anxiety Scale
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Anxiety symptom questionnaire
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuroinflammatory Biomarker Concentration
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Blood analysis for circulating concentration of neuroinflammatory protein, Interluken-6
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
EEG-fNRIS
時間枠:On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Combined EEG-fNIRS brain scan to identify regional brain activation. Specifically a resting state EEG-fNIRS will be utilized to compare the timecourse of frontal theta-, beta-, and alpha-wave peak frequency and absolute power versus BOLD signal (oxygenated hemogloben) in the frontal region. Synchronized EEG and fNIRS scans will aid in confirming type and degree of alterations in subcortical brain activity.
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年4月8日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月11日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する