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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 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Owen Griffith, PhD
  • Número de teléfono: 15709858794
  • Correo electrónico: omg5007@psu.edu

Ubicaciones de estudio

    • Pennsylvania
      • University Park, Pennsylvania, Estados Unidos, 16802
        • Recreation Building
        • Contacto:
          • Owen Griffith, PhD
          • Número de teléfono: 5709858794
          • Correo electrónico: omg5007@psu.edu
        • Investigador principal:
          • Owen Griffith, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concussion Symptoms Scales
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stroop Task
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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