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

Primary Purpose

Traumatic Brain Injury, Post-Concussion Syndrome, Concussion, Brain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Float-REST
Photobiomodulation
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Brain Injury focused on measuring Photobiomodulation, Flotation Restricted Environmental Stimulation Therapy

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Rockefeller Neuroscience Institute at West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard of Care

Float-REST

Photobiomodulation

Arm 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.

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.

Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 17, 2020
Last Updated
December 21, 2022
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05062148
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Research never commenced and will not be pursued as a viable opportunity at this time.
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Post-Concussion Syndrome, Concussion, Brain
Keywords
Photobiomodulation, Flotation Restricted Environmental Stimulation Therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm 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.
Arm Title
Float-REST
Arm Type
Active Comparator
Arm 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.
Arm Title
Photobiomodulation
Arm Type
Active Comparator
Arm Description
Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study.
Intervention Type
Other
Intervention Name(s)
Float-REST
Intervention Description
Subjects receiving Float-REST will float for 60 minutes three times a week.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention Description
Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.
Primary Outcome Measure Information:
Title
Change in sleep patterns as measured by OURA ring
Description
Oura Ring is a connected health device worn on the finger that measures sleep. Sleep summaries per day will be compared.
Time Frame
Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
Title
Change in depressive state as measured by BDI
Description
Beck Depression Inventory (BDI) - Self-assessment questionnaire to evaluate depressive state. Made of 21 questions, subjects can be classified from "normal" to extremely depressed
Time Frame
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
Title
Change in symptoms of Post-Concussion Syndrome as measured by SCAT5
Description
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.
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in symptoms of Post-Concussion Syndrome as measured by Rivermead
Description
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.
Time Frame
At baseline, daily until return to play, and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in stability and balance as measured by BESS
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in cognitive effort as measured by Dot Counting
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in anxiety levels as measured by BAI
Description
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
Time Frame
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
Title
Change in cognitive ability as measured by WAIS-IV
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in visuospatial memory as measured by BVMTR
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in auditory processing as measured by PASAT
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in front brain systems as measured by DKEFS
Description
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
Time Frame
At baseline and after the physician clears the subject for return to play, an average of 7-10 days
Title
Change in subjective recovery and stress as measured by SRSS
Description
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
Time Frame
Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
Title
Change in state and trait anxiety as measured by Spielberger STAI
Description
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
Time Frame
3 times per week until the physician clears the subject for return to play, an average of 7-10 days
Title
Change in brain function as measured by Dynavision
Description
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
Time Frame
3 times per week until the physician clears the subject for return to play, an average of 7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rockefeller Neuroscience Institute at West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

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

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