Phase 2
Completed N=18
Hyperbaric Treatment of Traumatic Brain Injury (TBI)
Source: ClinicalTrials.gov NCT01847755 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Improved Cerebral Perfusion — 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improved Cerebral Perfusion |
8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01847755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.