Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

9 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

24

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Owen Griffith, PhD
  • Numéro de téléphone: 15709858794
  • E-mail: omg5007@psu.edu

Lieux d'étude

    • Pennsylvania
      • University Park, Pennsylvania, États-Unis, 16802
        • Recreation Building
        • Contact:
          • Owen Griffith, PhD
          • Numéro de téléphone: 5709858794
          • E-mail: omg5007@psu.edu
        • Chercheur principal:
          • Owen Griffith, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Expérimental: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Concussion Symptoms Scales
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Stroop Task
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

8 avril 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner