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

NCT05062148 | Withdrawn

• 1 other identifier: 1904545091
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Photobiomodulation; Flotation Restricted Environmental Stimulation Therapy

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (3)

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.

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.

Other: Photobiomodulation

Interventions

Float-REST OTHER

Subjects receiving Float-REST will float for 60 minutes three times a week.

Float-REST

Photobiomodulation OTHER

Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.

Photobiomodulation

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: September 30, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 7, 2022
• Last Updated: December 23, 2022

Record last verified: 2021-09

Locations

US (1)