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A Meditation Intervention on Subconcussive Head Impacts

A Meditation Intervention on Subconcussive Head Impacts

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04225663
Enrollment
27
Registered
2020-01-13
Start date
2021-08-02
Completion date
2022-07-01
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury Trauma

Keywords

SUB-CONCUSSIVE HEAD IMPACTS, MEDITATION, adolescent athletes, young adult athletes

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.

Interventions

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

Sponsors

Mind and Life Institute, Hadley, Massachusetts
CollaboratorOTHER
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Heart Rate Variability (HRV)BaselineAn 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.
Measurement of SleepBaselineSleep 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)BaselineA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026