CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Oxygen at 1.5 ATA (atmospheres absolute).drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01847755
NCT01847755Phase 2Completed
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Phase 1-2 Study of Hyperbaric Treatment of Traumatic Brain Injury

Barry Miskin, MD·interventional·Posted May 7, 2013·Updated Apr 27, 2021

In Brief

A Phase 2 clinical trial evaluating Oxygen at 1.5 ATA (atmospheres absolute). for Traumatic Brain Injury. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesUnited States
CollaboratorsJupiter Medical Center

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2013
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 13.2 years ago

Interventions

Oxygen at 1.5 ATA (atmospheres absolute).drug

Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40,80,120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment.