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| ID | Type | Description | Link |
|---|---|---|---|
| 117686 | Other Identifier | FDA IND application number |
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| Name | Class |
|---|---|
| Jupiter Medical Center | OTHER |
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This study is designed to test the hypothesis that patients with Traumatic Brain Injury (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement is evidenced by increase in number of pixels on SPECT Scan and increased brain metabolism. Improvement may also be identified via cognitive assessments administered by Jupiter Medical Center Research Department.
Patients with Traumatic Brain Injury (TBI)have abnormal findings including hemorrhagic cortical contusions or petechial or foci of altered signal that represents white matter injury. MRI, CT or SPECT scans showing changes consistent with Traumatic Brain Injury (TBI)and or medical history of Traumatic Brain Injury (TBI)as evidenced by medical records will be screened for treatment with Hyperbaric. Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 atmospheres absolute(ATA).
Each patient will have a SPECT scan, cognitive assessment, and physician evaluation prior to first treatment and after 40, 80, and 120 treatments to document progress of the treatment (Harch et al, 2012). Cognitive assessment will include the Trail Making Test Parts A and B. Patient will be seen by physician to assess level of disability at each interval; the United States Department of Veteran Affairs' Evaluation of Cognitive Impairment and Subjective Symptoms (VAECI) (2012) tool will be utilized during the physician's evaluation as an objective measure of the patient's level of disability.
Hyperbaric treatments may be adjusted for patient comfort. If the SPECT scan, cognitive assessment and physician evaluation show improvement after 40 treatments, another 40 Hyperbaric(HBO)treatments will be administered. Treatments will be discontinued after a 40 session interval if the SPECT scan, cognitive assessment and physician evaluation show no improvement. The patient will also have a SPECT scan and cognitive assessment follow up 3 months after final Hyperbaric(HBO) treatment.The time points for evaluation of cognitive status and single-photon emission computerized tomography (SPECT) scan will be at at 40,80,120 Hyperbaric(HBO)treatments. Treatment will occur 5 times per week for approximately 24 weeks with another follow up 3 months post treatment. This will provide all data points for outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 120 Hyperbaric treatments at 1.5 ATA | Experimental | Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen at 1.5 ATA (atmospheres absolute). | Drug | Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40,80,120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improved Cerebral Perfusion | This study is designed to test the hypothesis that patients with TBI treated with HBO will show improvement in function and an increased blood flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement is evidenced by increase in number of pixels on SPECT scan and increased brain metabolism. | At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
Untreated Pneumothorax
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| Name | Affiliation | Role |
|---|---|---|
| Barry Miskin, MD | Jupiter Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Facts for Physicians about Mild Traumatic Brain Injury (2011, CS109152) Improvement in cerebral metabolism in chronic brain injury after hyperbaric oxygen therapy. International Journal of Neuroscience, 112(2), 119-131.. Harch, P. G., Andrews, S. R., Fogarty, E. F., Amen, D., Pezzullo, J. C., Lucarini, J., and Van Meter, K. W. (2012). A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. Journal of Neurotrauma, 29(1), 168-185. Harch, P. G., Kriedt, C., Van Meter, K. W., and Sutherland, R. J. (2007). Hyperbaric Oxygen Therapy in Global Cerebral Ischemia/Anoxia and Coma, in: Chapter 18, Textbook of Hyperbaric Medicine, 4th revised ed. K.K. Jain (ed.) Hogrefe and Huber Publishers: Seattle, pps. 223-261 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 120 Hyperbaric Treatments at 1.5 ATA | Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 120 Hyperbaric Treatments at 1.5 ATA | Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Improved Cerebral Perfusion | This study is designed to test the hypothesis that patients with TBI treated with HBO will show improvement in function and an increased blood flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement is evidenced by increase in number of pixels on SPECT scan and increased brain metabolism. | Posted | Count of Participants | Participants | At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment |
|
Approximately 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 120 Hyperbaric Treatments at 1.5 ATA | Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. Oxygen at 1.5 ATA (atmospheres absolute).: Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40, 80, 120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Hospitalized due to Hypertension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barry Miskin | Jupiter Medical Center | 561-263-5791 | clinicaltrials@jupitermed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Feb 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 18 |
| 1 |
| 18 |
| 0 |
| 18 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |