ClinicalTrials.Veeva

Menu

Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery

West Virginia University logo

West Virginia University

Status

Withdrawn

Conditions

Traumatic Brain Injury
Post-Concussion Syndrome
Concussion, Brain

Treatments

Other: Float-REST
Other: Photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05062148
1904545091

Details and patient eligibility

About

This research is being done to understand the role of different recovery methods in healing time after athletic or sports related concussion.

Full description

The investigators propose to assess PCS symptoms and how those symptoms are affected by Float-REST and PBM therapy in comparison to standard recovery practices. To do this, the investigators will operate in four phases.

Phase I - Initial Injury: High school aged athletes will be recruited from a WVU clinic in the acute phase of the athletes injury. Severe cases such as those with hemorrhaging and memory loss will be excluded from the study.

Phase II - Pre-intervention: Patients will be randomly assigned using R software (https://www.r-project.org) to three groups - Float-REST, PBM, or no intervention. Upon each subjects' first visit to Rockefeller Neuroscience Institute (RNI) a brief health questionnaire regarding the mechanism of injury will be administered (see below), the Rivermead Postconcussive Symptom Inventory (Rivermead), and the pre-intervention testing battery. All subjects will be instructed to complete the Rivermead as a daily log on a smartphone to monitor symptoms and follow the physician's orders for recovery (limited screen time, decreased homework load, etc.). Subjects will also be given a wearable sleep tracking device and instructed to wear it each night. Float-REST subjects will be shown the float tanks and will be given the opportunity to float for 5-10 minutes to become familiar with the sensation. PBM subjects will be shown the PBM bed and be permitted to test the brightness of the device. All subjects wishing to test either the PBM or the Float-REST will be required to take the SCAT5 Symptom Checklist first and not meet the exclusionary criteria contained in the Data Monitoring Plan.

Phase III - Intervention: All subjects will return to RNI three times per week. Subjects receiving Float-REST will float for 60 minutes, those receiving PBM will undergo a 20-minute therapy session, and both will complete the weekly testing (Table 1) afterwards. Subjects in the no intervention group will complete the weekly testing only. This will continue until the subjects' physicians clear them to return to play. The duration for return to play is an outcome measure of interest as it will expectedly vary subject to subject. If a recovery intervention is capable of shortening the time an athlete takes to return to competition, that particular intervention may be considered an effective strategy for accelerating recovery periods after sustaining a sports-related concussion.

Phase IV - Post-intervention: Once a subject has been cleared to return to play, the subject will come to RNI one final time and complete the post-concussion battery (Table 1). Upon completion, all patient's scores will be analyzed using R software (https://www.r-project.org). It is expected that those receiving Float-REST and/or PBM will have a greater improvement of cognitive scores than those just following physician orders.

End of Study: When the physician provides a medical clearance for the athlete to return to competition that will subsequently cease further data collection for that individual for this study.

Sex

All

Ages

14 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects between the ages of 14-17 currently involved in a sport and who sustained their concussion while playing said sport will be included.

Exclusion criteria

  • Subjects experiencing subcranial hemorrhaging, loss of memory, or extended loss of consciousness will be excluded

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Standard of Care
No Intervention group
Description:
Subjects will follow the standard of care, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Float-REST
Active Comparator group
Description:
Subjects will do Flotation Restricted Environmental Stimulation Therapy, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Treatment:
Other: Float-REST
Photobiomodulation
Active Comparator group
Description:
Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Treatment:
Other: Photobiomodulation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems