Clinical trial NCT04225663: A Meditation Intervention on Subconcussive Head Impacts
Official title: A Meditation Intervention on Subconcussive Head Impacts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury Trauma
Keywords: SUB-CONCUSSIVE HEAD IMPACTS
MEDITATION
adolescent athletes
young adult athletes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
First posted: 2020-01-13
Enrollment: 27
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Neuroimaging
timeFrame: Baseline
measure: Neuroimaging
timeFrame: 7 months
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: Baseline
measure: Heart Rate Variability (HRV)
timeFrame: 7 months
measure: Measurement of Sleep
timeFrame: Baseline
measure: Measurement of Sleep
timeFrame: 7 months
measure: The Fear of Pain Questionnaire-III (FPQ-III)
timeFrame: Baseline
measure: The Fear of Pain Questionnaire-III (FPQ-III)
timeFrame: 7 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christopher T Whitlow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: