Traumatic Brain InjuryNCT05062148
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
A study testing Float-REST and Photobiomodulation in people with Traumatic Brain Injury and Post-Concussion Syndrome, run by West Virginia University at 1 site in United States.
Trial summary
This research is being done to understand the role of different recovery methods in healing time after athletic or sports related concussion. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Traumatic Brain Injury, Post-Concussion Syndrome, Concussion, Brain
- What is being tested?
- Float-REST and Photobiomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2021to 7 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects between the ages of 14-17 currently involved in a sport and who sustained their concussion while playing said sport will be included.
Who cannot join
- Subjects experiencing subcranial hemorrhaging, loss of memory, or extended loss of consciousness will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
This research is being done to understand the role of different recovery methods in healing time after athletic or sports related concussion.
Read the 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.
- Being tested
- Float-REST, Photobiomodulation
- Keywords
- Photobiomodulation, Flotation Restricted Environmental Stimulation Therapy
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Float-RESTOther
Subjects receiving Float-REST will float for 60 minutes three times a week.
PhotobiomodulationOther
Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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 | 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. Receives: Other: Float-REST |
| Photobiomodulation | Active comparator | Subjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study. Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 times per week until the physician clears the subject for return to play, an average of 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completion7 Jun 2022
Why it stopped: Research never commenced and will not be pursued as a viable opportunity at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062148
- Sponsor's protocol ID
- 1904545091
- Status last verified
- Sep 2021
- First submitted
- 17 Jan 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
- ClinicalTrials.gov ID
- NCT05062148
- Acronym / sponsor ID
- 1904545091
- Keywords
- Photobiomodulation, Flotation Restricted Environmental Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research never commenced and will not be pursued as a viable opportunity at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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 | Other: Float-RESTSubjects will do Flotation Restricted Environmental Stimulation Therapy, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study. |
| Photobiomodulation | Active comparator | Other: PhotobiomodulationSubjects will do photobiomodulation, complete a daily log of symptoms, wear a fitness tracker daily for the length of the study. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects between the ages of 14-17 currently involved in a sport and who sustained their concussion while playing said sport will be included.
Key exclusion criteria (1 listed)
- Subjects experiencing subcranial hemorrhaging, loss of memory, or extended loss of consciousness will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Float-RESTSubjects receiving Float-REST will float for 60 minutes three times a week. | Other | Float-REST |
| PhotobiomodulationSubjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week. | Other | Photobiomodulation |
Primary outcome
Change in sleep patterns as measured by OURA ring
Time frame: Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
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
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
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
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
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
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
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: At baseline and after the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: 3 times per week until the physician clears the subject for return to play, an average of 7-10 days
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
Time frame: 3 times per week until the physician clears the subject for return to play, an average of 7-10 days
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Float-REST and Photobiomodulation in people with Traumatic Brain Injury and Post-Concussion Syndrome, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep patterns as measured by OURA ring (time frame: Daily from baseline until the physician clears the subject for return to play, an average of 7-10 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.