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

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

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury; Post-Concussion Syndrome; Concussion, Brain
• Intervention / Treatment: Other: Float-REST; Other: Photobiomodulation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Rockefeller Neuroscience Institute at West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Subjects will follow the standard of care, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Active Comparator: Float-REST; 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.	Other: Float-REST; Subjects receiving Float-REST will float for 60 minutes three times a week.
Active Comparator: Photobiomodulation; Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.	Other: Photobiomodulation; Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep patterns as measured by OURA ring	Oura Ring is a connected health device worn on the finger that measures sleep. Sleep summaries per day will be compared.	Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
Change in depressive state as measured by BDI	Beck Depression Inventory (BDI) - Self-assessment questionnaire to evaluate depressive state. Made of 21 questions, subjects can be classified from "normal" to extremely depressed	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
Change in symptoms of Post-Concussion Syndrome as measured by SCAT5	Sport Concussion Assessment Tool 5th edition (SCAT5) - Administered questionnaire consisting of 22 questions describing symptoms the subject may be experiencing, also includes intensity of symptoms. Latter portion includes cognitive evaluations.	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in symptoms of Post-Concussion Syndrome as measured by Rivermead	Rivermead Post-Concussion Symptom Inventory (Rivermead) - Administered self-assessment questionnaire (16 questions) used to evaluate severity of physical symptoms associated with TBIs that subjects have experience in the last 24-hours.	At baseline, daily until return to play, and after the physician clears the subject for return to play, an average of 7-10 days
Change in stability and balance as measured by BESS	Balancing Error Scoring System (BESS) - Objective test to assess static postural stability and balance. Subjects close eyes and perform a single, double, and tandem leg stance for 20 seconds each. Errors in stance are evaluated and tallied, then compared to standard values, more than 10 errors result in failure	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in cognitive effort as measured by Dot Counting	Dot Counting - Concentration-type task that allows researchers to measure cognitive effort. Lack of effort may be intentional or unintentional and is used to diagnose a multitude of issues such as schizophrenia and dementia	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in anxiety levels as measured by BAI	BECK ANXIETY INVENTORY (BAI): Self-assessment questionnaire to evaluate anxiety levels. Made of 21 questions, subjects can be classified from low to "potentially worrying" levels of anxiety	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
Change in cognitive ability as measured by WAIS-IV	WECHSLER ADULT INTELLIGENCE SCALE FOURTH EDITION (WAIS-IV): A type of intelligence test that also evaluates cognitive ability and compares it to a "normbased score." Includes 10 sub-tests, each evaluating either working memory, verbal comprehension, processing speed or perceptual reasoning	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in visuospatial memory as measured by BVMTR	BRIEF VISUOSPACIAL MEMORY TEST REVISED (BVMTR): A cognitive evaluation that has subjects memorize a card with multiple shapes/symbols in it for 10 seconds, then requires them to draw that card on a piece of paper with the shapes/symbols in the same locations. A delayed recall may be done as well. Subjects are also asked to identify which 12 shapes/symbols were on the card shown to them	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in auditory processing as measured by PASAT	PACED AUDITORY SERIAL ADDITION TEST (PASAT): An auditory processing assessment where subjects listen to a pre-recorded voice listing off various numbers in 3 second intervals. The numbers are single digits and must be added to the number said immediately before the new number	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in front brain systems as measured by DKEFS	DELIS-KAPLAN EXECUTIVE FUNCTION SYSTEM (DKEFS): A game-like assessment used to evaluate the function of the frontal lobe and front brain systems. Approved for both young children and adults, abstract and creative thinking are primarily assessed	At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Change in subjective recovery and stress as measured by SRSS	SUBJECTIVE RECOVERY STRESS STATE (SRSS): An 8 question validated assessment of subjective recovery and stress, containing 4 dimensions in recovery and 4 dimensions in stress	Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
Change in state and trait anxiety as measured by Spielberger STAI	SPIELBERGER STATE TRAIT ANXIETY INVENTORY: Commonly used measure of state and trait anxiety, and done with 20 very brief questions. This measure will be used only for the Float treatment condition, and done before and after each float session allowing the quantification of Float therapy effects on anxiety, which has been widely published in the Float therapy literature	3 times per week until the physician clears the subject for return to play, an average of 7-10 days
Change in brain function as measured by Dynavision	DYNAVISION: The Dynavision is a programmable light board that can be used to assess reaction time, vision processing speed, eye hand coordination, visual field, and ocular motor performance, and has been used previously for concussion assessment and mitigation	3 times per week until the physician clears the subject for return to play, an average of 7-10 days

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Photobiomodulation; Flotation Restricted Environmental Stimulation Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 1904545091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No