A Meditation Intervention on Subconcussive Head Impacts
Primary Purpose
Head Injury Trauma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Meditation
Sponsored by
About this trial
This is an interventional basic science trial for Head Injury Trauma focused on measuring SUB-CONCUSSIVE HEAD IMPACTS, MEDITATION, adolescent athletes, young adult athletes
Eligibility Criteria
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.
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm 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.
The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.
Outcomes
Primary Outcome Measures
Neuroimaging
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Neuroimaging
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Secondary Outcome Measures
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.
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.
Measurement of Sleep
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
Measurement of Sleep
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
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.
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.
Full Information
NCT ID
NCT04225663
First Posted
January 7, 2020
Last Updated
July 5, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Mind and Life Institute, Hadley, Massachusetts
1. Study Identification
Unique Protocol Identification Number
NCT04225663
Brief Title
A Meditation Intervention on Subconcussive Head Impacts
Official Title
A Meditation Intervention on Subconcussive Head Impacts
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Mind and Life Institute, Hadley, Massachusetts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury Trauma
Keywords
SUB-CONCUSSIVE HEAD IMPACTS, MEDITATION, adolescent athletes, young adult athletes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.
Intervention Type
Behavioral
Intervention Name(s)
Guided Meditation
Intervention Description
Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Primary Outcome Measure Information:
Title
Neuroimaging
Description
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Time Frame
Baseline
Title
Neuroimaging
Description
Brain structural data will be acquired with Siemens Skyra 3T MRI with 32-channel head coil.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Heart Rate Variability (HRV)
Description
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.
Time Frame
Baseline
Title
Heart Rate Variability (HRV)
Description
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.
Time Frame
7 months
Title
Measurement of Sleep
Description
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
Time Frame
Baseline
Title
Measurement of Sleep
Description
Sleep data will be acquired with the Biostrap heart rate variability (HRV) wristband. Sleep will be measured in hours per night.
Time Frame
7 months
Title
The Fear of Pain Questionnaire-III (FPQ-III)
Description
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.
Time Frame
Baseline
Title
The Fear of Pain Questionnaire-III (FPQ-III)
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T Whitlow, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Meditation Intervention on Subconcussive Head Impacts
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