Status:
COMPLETED
Hyperbaric Treatment of Traumatic Brain Injury (TBI)
Lead Sponsor:
Barry Miskin, MD
Collaborating Sponsors:
Jupiter Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01847755
Start Date
April 1 2013
End Date
December 1 2020
Last Update
April 27 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jupiter Medical Center
Jupiter, Florida, United States, 33458