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Trial record 29 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

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ClinicalTrials.gov Identifier: NCT00810615
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
George Wolf, San Antonio Military Medical Center

Brief Summary:
The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures. Subjects are enrolled by invitation only.

Condition or disease Intervention/treatment Phase
Brain Injury, Chronic Other: Hyperbaric oxygen @ 2.4 ATA Other: Sham treatment Phase 1 Phase 2

Detailed Description:
The Agency for Healthcare Research and Quality (AHRQ) did a comprehensive review of the literature focusing on TBI, stroke and cerebral palsy in Sep 2003. The study design and goals were based on the AHRQ recommendations for future hyperbaric oxygen for TBI research. This report stated, "The most important gap in the evidence is a lack of a good quality time-series study or controlled trial of the effects of HBOT on cognition, memory, and functional status in patients with deficits due to mild and moderate chronic TBI." The AHRQ Evidence Report further stated, "Lack of agreement on the dosage of HBOT and the duration of treatment is an important barrier to conducting good-quality clinical studies…Good-quality dose-ranging studies of HBOT for brain injury can be done, based on the model used by pharmaceutical manufacturers and the FDA. It is likely that the dosage of HBOT needs to be individualized based on the patient's age, clinical condition, and other factors". Although there are many anecdotal cases of TBI improvement with HBO, this case is backed with non-subjective data. The biological basis for why breathing 100% oxygen under pressurized conditions improves chronic neurological trauma remains unclear. There is some evidence that chronic TBI effects are related to the demyelization effect linked to the expression of a specific protease, calpain. This protease is also seen in demyelination delayed effects of carbon monoxide poisoning which is slowed by treatment with HBO. The "idling neuron" theory advocated in neurological studies suggest that HBO may increase metabolic performance of chronically impaired neurons that were marginally capable, enabling restoration of full function leading in turn to increased integrative plasticity. HBO has been shown to increase recruitment of stem cells from the bone marrow, suggesting that HBO may increase the rate at which damaged neuronal tissue can be reconstituted de novo. The proposed research will treat 25 subjects using HBO (2.4 ATA breathing 100% oxygen) and 25 subjects in a sham HBO treatment (1.3 ATA breathing air). Computer-based cognitive testing and the Post-traumatic Stress Disorder Checklist for Military (PCL-M) will be administered pre- and post-HBOT as well as at intervals throughout the treatment. The cognitive test results and stem cell results will be analyzed within each subject at the various treatment points as well as cohort groups between each treatment leg. Cognitive test scores will also be compared to cognitive test population reference bases matched for gender and age. The Agency for Healthcare Research and Quality 2003 report also stated, "If there is a 1 percent chance that the treatment works, a rational decision maker would try it—there is a potential gain and no potential loss. On the other hand, if there are proven harms, and their severity and frequency are well described, the probability that the treatment works would have to be higher before most people would try it"

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)
Study Start Date : February 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham treatment
Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Other: Sham treatment
Other Name: sham exposure; 1.3 ATA air

Experimental: Hyperbaric oxygen 2.4 ATA
Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Other: Hyperbaric oxygen @ 2.4 ATA
Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Other Names:
  • hyperbaric oxygen
  • HBOT
  • HBO




Primary Outcome Measures :
  1. Computer Cognitive Test Scores - ImPACT Verbal Memory [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.

  2. Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores [ Time Frame: baseline compared to the change at post hyperbaric exposures (30) series and the six weeks post hyperbaric exposure series ]
    The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating "not at all", 2= "a little bit", 3= "moderately", 4= "quite a bit" and 5 designating "extremely". A sample complaint would be "repeated, disturbing dreams of a stressful military experience". Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change.

  3. Computer Cognitive Test Scores - ImPACT Visual Memory [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.

  4. Computer Cognitive Test Scores - ImPACT Processing Speed [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.

  5. Computer Cognitive Test Scores - ImPACT Reaction Time [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.

  6. Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.

  7. Computer Cognitive Test Scores - BrainCheckers Code Substitution [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.

  8. Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.

  9. Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.

  10. Computer Cognitive Test Scores - BrainCheckers Matching To Sample [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.

  11. Computer Cognitive Test Scores - BrainCheckers Code Sub Recall [ Time Frame: Baseline and six weeks post hyperbaric exposure series ]
    BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.


Secondary Outcome Measures :
  1. Functional MRI [ Time Frame: six weeks post hyperbaric exposure series ]
  2. Stem Cells: CD_34 [ Time Frame: six weeks post hyperbaric exposure series ]
    A non-parametric regression 14 using the Theil estimator was fit to the observed data in order to demonstrate general trends for relations between measures of cognitive functioning and increased stem cells.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neurology diagnosis of mild to moderate TBI
  • injury sustained during OIF/OEF military activities
  • perception of cognitive dysfunction following their injury
  • stable mental status for at least two months
  • stable psychotropic medication history for at least one month
  • ability to perform computer based cognitive testing (must be capable using a mouse and PDA pointer and readily view the displays)
  • TBI occurrence since 7 October 2001
  • ability to consent

Exclusion Criteria:

  • medical conditions that prevent subject from participating in hyperbaric environments
  • previous hyperbaric oxygen treatments since being diagnosed with TBI
  • history of alcohol abuse
  • history of drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810615


Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
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Study Director: E. George Wolf, M.D. SAMMC Hyperbaric Medicine
Principal Investigator: Leonardo C Profenna, M.D. SAMMC Hyperbaric Medicine

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Responsible Party: George Wolf, Study Director, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT00810615     History of Changes
Other Study ID Numbers: FWH20080137H
First Posted: December 18, 2008    Key Record Dates
Results First Posted: August 13, 2018
Last Update Posted: August 13, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Wolf, San Antonio Military Medical Center:
chronic TBI
cognitive function
PTSD
HBO
hyperbaric
oxygen
chronic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Injury, Chronic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic