NCT04225663

A Meditation Intervention on Subconcussive Head Impacts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to explore potential methods of rehabilitating changes observed from repetitive head impacts. Participation in this study will involve functional magnetic resonance (fMRI) imaging, aerobic testing, heart rate variability (HRV) wrist monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out survey information concerning subjective well-being.

Detailed description

COLLEGE ATHLETES: At each study visit, participants will undergo an fMRI-cerebrovascular reactivity (CVR) challenge scanning session as well as an aerobic exercise test on a stationary bike. During the CVR-fMRI scan, the participant will wear a mask that will deliver a blend of oxygen and nitrogen at varying amounts while lying in an MRI scanner. During the aerobic stationary bike assessment, the participant will pedal at a steady state against applied resistance for 10 minutes while wearing an ECG heart rate monitor to observe heart rate. A Biostrap heart rate variability (HRV) wrist monitor will be provided which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. After the conclusion of the sport's season, there will be a follow up scanning session. After the post-season scan, the participant will participate in a breath work meditation intervention over the following two months, twice a week for a 30 minute meditation session. HIGH SCHOOL ATHLETES: Participants will be given a Biostrap HRV monitor which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. High school athletes will be randomized into one of two study groups, the control group or the intervention group. The intervention group will receive guided meditation over 2 months (twice a week for 30 mins each session), and will ride a stationary bike at 3 time points. The control group will proceed about their lives normally.

Conditions

• Head Injury Trauma

Interventions

Type	Name	Description
BEHAVIORAL	Guided Meditation	Participants will meditate in response to the guidance provided by a trained meditation coach in person.

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-06-01
• Completion: 2022-07-01
• First posted: 2020-01-13
• Last updated: 2023-07-07

Locations

1 site across 1 country: United States