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

9. juni 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Owen Griffith, PhD
  • Telefonnummer: 15709858794
  • E-post: omg5007@psu.edu

Studiesteder

    • Pennsylvania
      • University Park, Pennsylvania, Forente stater, 16802
        • Recreation Building
        • Ta kontakt med:
        • Hovedetterforsker:
          • Owen Griffith, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Eksperimentell: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concussion Symptoms Scales
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stroop Task
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

8. april 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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