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Search / Trial NCT01847755

Hyperbaric Treatment of Traumatic Brain Injury (TBI)

Launched by BARRY MISKIN, MD · May 6, 2013

Trial Information

Current as of July 01, 2025

Completed

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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

About Barry Miskin, Md

Dr. Barry Miskin, MD, is a distinguished clinical trial sponsor with extensive experience in advancing medical research and patient care. With a commitment to innovative therapeutic solutions, Dr. Miskin leads trials that focus on improving treatment outcomes across various healthcare disciplines. His expertise not only encompasses the design and implementation of clinical studies but also emphasizes adherence to regulatory standards and ethical considerations. Through collaborative partnerships with research institutions and healthcare professionals, Dr. Miskin aims to contribute significantly to the development of safe and effective therapies, ultimately enhancing the quality of life for patients.

Locations

Jupiter, Florida, United States

Patients applied

0 patients applied

Trial Officials

Barry Miskin, MD

Principal Investigator

Jupiter Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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