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NCT Number: NCT04225663

A Meditation Intervention on Subconcussive Head Impacts

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.

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Key information

Conditions

Head Injury Trauma

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Meditation

Behavioral

Participants will meditate in response to the guidance provided by a trained meditation coach in person.

Primary outcomes

  1. Neuroimaging

    Time frame: Baseline

    Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.

  2. Neuroimaging

    Time frame: 7 months

    Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.

Secondary outcomes

  1. Heart Rate Variability (HRV)

    Time frame: Baseline

    An aerobic bike test will be used to examine HRV. Upon conclusion of the exercise challenge, HRV will be measured using standard methods, During the warm up and test, they will be wearing apical ECG leads to record heart rate activity.

  2. Heart Rate Variability (HRV)

    Time frame: 7 months

    An aerobic bike test will be used to examine HRV. Upon conclusion of the exercise challenge, HRV will be measured using standard methods, During the warm up and test, they will be wearing a Biostrap ECG heart rate monitor to record heart rate activity.

  3. Measurement of Sleep

    Time frame: Baseline

    Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.

  4. Measurement of Sleep

    Time frame: 7 months

    Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.

  5. The Fear of Pain Questionnaire-III (FPQ-III)

    Time frame: Baseline

    A 30-item questionnaire used to assess the fear of pain, including Severe Pain, Minor Pain, and Medical Pain subscales. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extreme), and the total score ranges from 30 to 150.

  6. The Fear of Pain Questionnaire-III (FPQ-III)

    Time frame: 7 months

    A 30-item questionnaire used to assess the fear of pain, including Severe Pain, Minor Pain, and Medical Pain subscales. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extreme), and the total score ranges from 30 to 150.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Mind and Life Institute, Hadley, Massachusetts

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Jul 7, 2023

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.

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