Overview

Hyperbaric Treatment of Traumatic Brain Injury (TBI)

Status:
Completed
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barry Miskin, MD
Collaborator:
Jupiter Medical Center
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