Recreation Building
University Park, Pennsylvania, 16802, United States
NCT Number: NCT07642739
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.
Trial opening soon.
Get Notified14 year–35 year
All sexes
Interventional
Not applicable
University Park, Pennsylvania, 16802, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 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.
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuropsychological test of processing speed and inhibition
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuropsychological measure of attention and memory
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Depression symptom questionnaire
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Anxiety symptom questionnaire
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Penn State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07670195
Brain Concussion, Brain Diseases
View Trial DetailsNCT07303933
Behavior, Brain Concussion
University Park, Pennsylvania, United States
View Trial DetailsNCT07082218
Anxiety Disorders, Behavior
Aurora, Colorado, United States
View Trial DetailsNCT06644131
Brain Concussion, Brain Diseases
Odense, Denmark
View Trial Details