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Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Primary Purpose

Post-Concussion Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Treatment
Placebo gas
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have been evaluated within 48 hours of injury and given a diagnosis of concussion by a medical professional Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ). Exclusion Criteria: Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to: Pulmonary: COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs Current pneumothorax or previous spontaneous pneumothorax Cardiac: Uncontrolled HTN (systolic >180 or diastolic >100) Known Ejection fraction < 35% Pacemaker / ICD in place (not approved for chamber use) Hematological/Oncological: Current chemotherapeutic drug use, and past history of bleomycin use. Hereditary Spherocytosis Sickle cell anemia Neurological and Psychological: Implanted nerve stimulators Uncontrolled seizure disorder Drug or alcohol abuse/dependence Current treatment for alcohol cessation with disulfiram Claustrophobia Head and Neck: Inability to equilibrate the pressure of middle ears and sinuses Current or previous retinal detachment Retinal or vitreous surgery within the past 3 months Miscellaneous: Current fever or active infection Implanted devices not on the approved list for use with HBOT Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for >2 years. Undergoing vestibular or other therapy during the intervention Planning a change in medication during the intervention Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study. Asthma Optic neuritis Otosclerosis surgery Thoracic surgery Chronic sinusitis Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician. Antabuse - Predisposes to oxygen toxicity Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria Meclizine - Predisposes to oxygen toxicity Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment. Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings. Narcotics - Can lead to cessation of the hypoxic respiratory drive. Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory. Penicillin - Predisposes to oxygen toxicity Promethazine (Phenergan) - Predisposes to oxygen toxicity. Corticosteroids - Decreases the threshold for oxygen toxicity. Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.

Sites / Locations

  • Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HBOT Arm

Control Arm

Arm Description

Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions

Placebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions

Outcomes

Primary Outcome Measures

Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."

Secondary Outcome Measures

Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Change in quality of life as measured by the Short Form Survey (SF-36)
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Change in quality of life as measured by the Short Form Survey (SF-36)
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating
Percentage of participant feeling of back to normal, pre-injury self at baseline is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Number of participants with adverse events
Safety (Tolerability) of the treatment is assessed by monitoring and evaluating Adverse events (AE)s by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment
Number of participants who missed the treatment
The count of participants who missed the treatment is assessed.

Full Information

First Posted
November 17, 2022
Last Updated
April 17, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05643482
Brief Title
Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
Official Title
Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention. Specific Aims: Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury. Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery. Improve quality of life as measured by the 36-Item Short Form Survey (SF-36). Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized between HBOT and control group with a 1:1 allocation ratio, stratified by decade of age and gender via computer generated block randomization with block size of four.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBOT Arm
Arm Type
Experimental
Arm Description
Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Placebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen Treatment
Intervention Description
Pressurization at 2.0 ATA with 100% oxygen
Intervention Type
Other
Intervention Name(s)
Placebo gas
Intervention Description
Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air
Primary Outcome Measure Information:
Title
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Description
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Time Frame
Baseline, immediately after treatment
Title
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Description
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Time Frame
Baseline, 1 month after treatment
Secondary Outcome Measure Information:
Title
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Description
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Time Frame
Baseline, immediately after last treatment
Title
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Description
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Time Frame
Baseline, 1 month after treatment
Title
Change in quality of life as measured by the Short Form Survey (SF-36)
Description
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Time Frame
Baseline, immediately after treatment
Title
Change in quality of life as measured by the Short Form Survey (SF-36)
Description
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Time Frame
Baseline, 1 month
Title
Global Impression of Change (GIC)
Description
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Time Frame
Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Title
Global Impression of Change (GIC)
Description
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Time Frame
Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Title
Global Impression of Change (GIC)
Description
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Time Frame
Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Title
Global Impression of Change (GIC)
Description
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Time Frame
Baseline, after 20 treatment sessions (approximately 3 weeks after starting treatment)
Title
Global Impression of Change (GIC)
Description
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Time Frame
Baseline, 1 month post-treatment
Title
Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating
Description
Percentage of participant feeling of back to normal, pre-injury self at baseline is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline
Title
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Description
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Title
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.
Description
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Title
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Description
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Title
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Description
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline, after 20 treatment sessions (approximately 4 weeks after starting treatment)
Title
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Description
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Time Frame
Baseline, 1 month post-treatment
Title
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Description
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Time Frame
Baseline, immediately after last treatment
Title
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Description
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Time Frame
Baseline, 1 month after treatment
Title
Number of participants with adverse events
Description
Safety (Tolerability) of the treatment is assessed by monitoring and evaluating Adverse events (AE)s by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment
Time Frame
1 month after treatment
Title
Number of participants who missed the treatment
Description
The count of participants who missed the treatment is assessed.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have been evaluated within 48 hours of injury and given a diagnosis of concussion by a medical professional Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ). Exclusion Criteria: Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to: Pulmonary: COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs Current pneumothorax or previous spontaneous pneumothorax Cardiac: Uncontrolled HTN (systolic >180 or diastolic >100) Known Ejection fraction < 35% Pacemaker / ICD in place (not approved for chamber use) Hematological/Oncological: Current chemotherapeutic drug use, and past history of bleomycin use. Hereditary Spherocytosis Sickle cell anemia Neurological and Psychological: Implanted nerve stimulators Uncontrolled seizure disorder Drug or alcohol abuse/dependence Current treatment for alcohol cessation with disulfiram Claustrophobia Head and Neck: Inability to equilibrate the pressure of middle ears and sinuses Current or previous retinal detachment Retinal or vitreous surgery within the past 3 months Miscellaneous: Current fever or active infection Implanted devices not on the approved list for use with HBOT Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for >2 years. Undergoing vestibular or other therapy during the intervention Planning a change in medication during the intervention Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study. Asthma Optic neuritis Otosclerosis surgery Thoracic surgery Chronic sinusitis Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician. Antabuse - Predisposes to oxygen toxicity Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria Meclizine - Predisposes to oxygen toxicity Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment. Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings. Narcotics - Can lead to cessation of the hypoxic respiratory drive. Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory. Penicillin - Predisposes to oxygen toxicity Promethazine (Phenergan) - Predisposes to oxygen toxicity. Corticosteroids - Decreases the threshold for oxygen toxicity. Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Kundig
Phone
214/648-2658
Email
Charles.Kundig@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanti Pinto, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Kundig
Phone
214-648-2658
Email
HBOTconcussion@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Jill Morales, MS
Phone
214-648-2650
Email
HBOTconcussion@utsouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

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