A Meditation Intervention on Subconcussive Head Impacts
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJuly 7, 2023
November 1, 2022
10 months
January 7, 2020
July 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Heart Rate Variability (HRV)
Baseline
Heart Rate Variability (HRV)
7 months
Measurement of Sleep
Baseline
Measurement of Sleep
7 months
The Fear of Pain Questionnaire-III (FPQ-III)
Baseline
- +1 more secondary outcomes
Study Arms (2)
Intervention group
ACTIVE COMPARATORThe 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.
Control group
NO INTERVENTIONThe Control group will not have intervention. They will have quiet, independent study for 30-minute sessions.
Interventions
Participants will meditate in response to the guidance provided by a trained meditation coach in person.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher T Whitlow, MD, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 13, 2020
Study Start
August 2, 2021
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
July 7, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share