Clinical trial NCT05062148: Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
Official title: Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Post-Concussion Syndrome
Concussion, Brain
Keywords: Photobiomodulation
Flotation Restricted Environmental Stimulation Therapy
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned using R software (https://www.r-project.org) to three groups - Float-REST, PBM, or no intervention.

All subjects will return to RNI three times per week (intervention visits). 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 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.
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep patterns as measured by OURA ring
timeFrame: Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
measure: Change in depressive state as measured by BDI
timeFrame: At baseline, 3 times per week until return to play, and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in symptoms of Post-Concussion Syndrome as measured by SCAT5
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in symptoms of Post-Concussion Syndrome as measured by Rivermead
timeFrame: At baseline, daily until return to play, and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in stability and balance as measured by BESS
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in cognitive effort as measured by Dot Counting
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in anxiety levels as measured by BAI
timeFrame: At baseline, 3 times per week until return to play, and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in cognitive ability as measured by WAIS-IV
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in visuospatial memory as measured by BVMTR
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in auditory processing as measured by PASAT
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in front brain systems as measured by DKEFS
timeFrame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
measure: Change in subjective recovery and stress as measured by SRSS
timeFrame: Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
measure: Change in state and trait anxiety as measured by Spielberger STAI
timeFrame: 3 times per week until the physician clears the subject for return to play, an average of 7-10 days
measure: Change in brain function as measured by Dynavision
timeFrame: 3 times per week until the physician clears the subject for return to play, an average of 7-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: