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Hyperbaric Treatment of Traumatic Brain Injury (TBI)

NCT01847755 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-04-27

Study results available
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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.

Conditions

Interventions

DRUG

Oxygen at 1.5 ATA (atmospheres absolute).

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.

Sponsors & Collaborators

  • Jupiter Medical Center

    collaborator OTHER

  • Barry Miskin, MD

    lead OTHER

Principal Investigators

  • Barry Miskin, MD · Jupiter Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847755 on ClinicalTrials.gov