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Hyperbaric Treatment of Traumatic Brain Injury (TBI) (TBI)

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ClinicalTrials.gov Identifier: NCT01847755
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
Jupiter Medical Center
Information provided by (Responsible Party):
Barry Miskin, MD, Jupiter Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Oxygen at 1.5 ATA (atmospheres absolute). Phase 1 Phase 2

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1-2 Study of Hyperbaric Treatment of Traumatic Brain Injury
Study Start Date : April 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Other Name: 02 or Oxygen


Outcome Measures
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Primary Outcome Measures :
  1. Improved cognitive function [ Time Frame: At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment ]
    Improved (increase number of pixels on SPECT scan) blood flow to brain, improved (cognitive assessment score) cognitive function, improvement in symptoms and Evaluation of Cognitive Impairment score.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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Stage Traumatic Brain Injury (TBI)as demonstrated by loss of consciousness due to the injury that is a minimum of 1 year old
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Women: Negative pregnancy test: If sexually active, women will take contraceptive measures for the duration of the treatments. Medically acceptable contraceptives include: 1) surgical sterilization (such as tubal ligation, hysterectomy, 2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), 3) barrier methods (such as a condom or diaphragm) used with a spermicide, or 4) an intrauterine device (IUD).
  • Subjects capacity to give legally effective consent (patient is alert and oriented x3).
  • Signed consent form approved by the Institutional Review Board prior to patient entry
  • History of lung disease (e.g. bronchitis, asthma) requires chest x-ray prior to inclusion in the study

Exclusion Criteria:

  • Untreated Pneumothorax

    • Anti-metabolites/chemotherapeutic agents (is used currently)
    • Mafenide Acetate (sulfamylon): antibacterial drug; peripheral vasodilation Disulfiram (Antabuse)
    • History of spontaneous pneumothorax
    • Seizure Disorder
    • Acute Upper Respiratory Infection
    • Acute High Fever
    • Acute Viral Infection
    • Participation in another experimental trial with active interventions
    • Women who are pregnant or lactating
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01847755


Locations
United States, Florida
Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Research Dept.    561-263-5791    clinicaltrials@jupitermed.com   
Principal Investigator: Barry Miskin, MD         
Sponsors and Collaborators
Barry Miskin, MD
Jupiter Medical Center
Investigators
Principal Investigator: Barry Miskin, MD Jupiter Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
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

Responsible Party: Barry Miskin, MD, Principal Investigator, Jupiter Medical Center
ClinicalTrials.gov Identifier: NCT01847755     History of Changes
Other Study ID Numbers: JMC-TBI-001
117686 ( Other Identifier: FDA IND application number )
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System