A Meditation Intervention on Subconcussive Head Impacts

Wake Forest University (WFU)

Status: Completed

Conditions: Head Injury Trauma

Treatments: Behavioral: Guided Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04225663

IRB00062234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants recruited for this study will be comprised of adolescent and young adult athletes (age-range 13-25) engaged in high school or college contact athletics who are enrolled in an ongoing NIH funded study of subconcussive head impact exposure (Whitlow: R01 NS091602), which acquires pre- and post-season MRI scans and cognitive testing.

Exclusion criteria

• Athletes will be excluded from the study if they suffer a concussion over the sports season or during the course of the proposed mediation intervention study. Athletes will be excluded if they experience claustrophobia entering an MRI scanner.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

The Intervention group will receive 30-minute sessions of guided meditation. During meditation, they will lie down with their backs and torsos elevated by a mat/soft blocks. They will undergo guided breath work.

Treatment:

Behavioral: Guided Meditation

Control group

No Intervention group

Description:

The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.