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.

Study Overview

• Status: Completed
• Conditions: Head Injury Trauma
• Intervention / Treatment: Behavioral: Guided Meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; 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.	Behavioral: Guided Meditation; Participants will meditate in response to the guidance provided by a trained meditation coach in person.
No Intervention: Control group; The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroimaging	Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.	Baseline
Neuroimaging	Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV)	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.	Baseline
Heart Rate Variability (HRV)	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.	7 months
Measurement of Sleep	Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.	Baseline
Measurement of Sleep	Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.	7 months
The Fear of Pain Questionnaire-III (FPQ-III)	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.	Baseline
The Fear of Pain Questionnaire-III (FPQ-III)	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.	7 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Mind and Life Institute, Hadley, Massachusetts
• Investigators: Principal Investigator: Christopher T Whitlow, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: adolescent athletes; SUB-CONCUSSIVE HEAD IMPACTS; MEDITATION; young adult athletes
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: IRB00062234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No