A Meditation Intervention on Subconcussive Head Impacts

NCT ID: NCT04225663

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Head Injury Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Guided Meditation

Intervention Type BEHAVIORAL

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

Control group

The Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guided Meditation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mind and Life Institute, Hadley, Massachusetts

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher T Whitlow, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00062234

Identifier Type: -

Identifier Source: org_study_id

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