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Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Primary Purpose

Post-Concussion Syndrome, Traumatic Brain Injury

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen
No Hyperbaric Oxygen
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Hyperbaric Oxygen Treatment, Mild Traumatic Brain Injury, Persistent Post-Concussion Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults, 18-65 years old.
  2. One or more mild TBI's due to blunt or blast injury.
  3. Meets criteria for PPCS.
  4. Ability to complete the NSI.
  5. Ability to complete the PCL-M or C.
  6. Ability to complete CAPS if needed.
  7. Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI.
  8. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST).
  9. Ability to complete a urine toxicology screen for drugs of abuse.
  10. Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.
  11. Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents.
  12. Otherwise good health.

Exclusion Criteria:

  1. Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).
  2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
  3. Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).
  4. Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.
  5. Participation in another experimental trial with active intervention.
  6. High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments).
  7. Previous HBOT.
  8. History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI.
  9. Past or current history of mental retardation.
  10. Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).
  11. Pre-injury psychiatric disorders for which the patient was on medication at the time of the brain injury responsible for the patient's diagnosis of TBI/PPCS.
  12. Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).
  13. Active malignancy undergoing treatment.
  14. Taking lithium.

Sites / Locations

  • Louisiana State University Health Sciences Center-New OrleansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hyperbaric Oxygen Therapy (HBOT)

No Hyperbaric Oxygen Treatment (HBOT)

Arm Description

Hyperbaric Oxygen Therapy at 1.5 ATA (atmospheres absolute). The subjects will receive 40 low pressure HBOT's on a once/day, 5d/week eight week schedule.

Subjects will receive eight weeks of no hyperbaric treatment while they continue any pre-study maintenance medication and/or pre-study counseling. Subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.

Outcomes

Primary Outcome Measures

Working Memory
Neurobehavioral Symptom Inventory (NSI)

Secondary Outcome Measures

Wechsler Abbreviated Scale of Intelligence II (WASI-II)
Wechsler Memory Scale-IV (WMS-IV
Rey Auditory Verbal Learning Test (RAVLT)
Benton Visual Retention Test with Alternate Forms (Benton VRT)
Stroop Color-Word Interference Test
Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)
Category Fluency Test (Animal)
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
Pittsburgh Sleep Quality Index (PSQI)
Quality of Life After Brain Injury (QOLIBRI)

Full Information

First Posted
March 14, 2014
Last Updated
April 16, 2017
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02089594
Brief Title
Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
Official Title
Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).
Detailed Description
This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA (atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic continuously for at least six months from one or more mild traumatic brain injuries will be enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment period the no treatment group will be crossed over to receive 40 HBOTs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome, Traumatic Brain Injury
Keywords
Hyperbaric Oxygen Treatment, Mild Traumatic Brain Injury, Persistent Post-Concussion Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Randomized prospective controlled
Masking
Investigator
Masking Description
Neuropsychological testers and neuropsychologist blinded to treatment group.
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Therapy (HBOT)
Arm Type
Experimental
Arm Description
Hyperbaric Oxygen Therapy at 1.5 ATA (atmospheres absolute). The subjects will receive 40 low pressure HBOT's on a once/day, 5d/week eight week schedule.
Arm Title
No Hyperbaric Oxygen Treatment (HBOT)
Arm Type
Experimental
Arm Description
Subjects will receive eight weeks of no hyperbaric treatment while they continue any pre-study maintenance medication and/or pre-study counseling. Subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Oxygen
Other Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
HBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes.
Intervention Type
Drug
Intervention Name(s)
No Hyperbaric Oxygen
Other Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
Subjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.
Primary Outcome Measure Information:
Title
Working Memory
Time Frame
One week after final HBOT
Title
Neurobehavioral Symptom Inventory (NSI)
Time Frame
One week after final HBOT
Secondary Outcome Measure Information:
Title
Wechsler Abbreviated Scale of Intelligence II (WASI-II)
Time Frame
2 months after final HBOT
Title
Wechsler Memory Scale-IV (WMS-IV
Time Frame
2 months after final HBOT
Title
Rey Auditory Verbal Learning Test (RAVLT)
Time Frame
2 months after final HBOT
Title
Benton Visual Retention Test with Alternate Forms (Benton VRT)
Time Frame
2 months after final HBOT
Title
Stroop Color-Word Interference Test
Time Frame
2 months after final HBOT
Title
Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)
Time Frame
2 months after final HBOT
Title
Category Fluency Test (Animal)
Time Frame
2 months after final HBOT
Title
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
Time Frame
2 months after final HBOT
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
2 months after final HBOT
Title
Quality of Life After Brain Injury (QOLIBRI)
Time Frame
2 months after final HBOT

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: Adults, 18-65 years old. One or more mild TBI's due to blunt or blast injury. Meets criteria for PPCS. Ability to complete the NSI. Ability to complete the PCL-M or C. Ability to complete CAPS if needed. Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST). Ability to complete a urine toxicology screen for drugs of abuse. Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment. Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents. Otherwise good health. Exclusion Criteria: Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema). Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year). Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI). Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder. Participation in another experimental trial with active intervention. High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments). Previous HBOT. History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI. Past or current history of mental retardation. Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision). Pre-injury psychiatric disorders for which the patient was on medication at the time of the brain injury responsible for the patient's diagnosis of TBI/PPCS. Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision). Active malignancy undergoing treatment. Taking lithium.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cara J Rowe, MSW
Phone
504-427-5632
Email
cjoh26@lsuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Harch, MD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Health Sciences Center-New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul G Harch, MD
First Name & Middle Initial & Last Name & Degree
Susan Andrews, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32189664
Citation
Harch PG, Andrews SR, Rowe CJ, Lischka JR, Townsend MH, Yu Q, Mercante DE. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. Med Gas Res. 2020 Jan-Mar;10(1):8-20. doi: 10.4103/2045-9912.279978.
Results Reference
derived
Links:
URL
http://hbottbistudy.org/
Description
study website

Learn more about this trial

Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

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