Hyperbaric Treatment of Traumatic Brain Injury (TBI)
Completed · Phase 1/Phase 2
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT01847755
- Run by
- Barry Miskin, MD
- People needed
- 18
- Starts
- 2013-04-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2021-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jupiter Medical Center — Jupiter, Florida, United States
Full record on ClinicalTrials.gov
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