Trial Outcomes & Findings for Hyperbaric Treatment of Traumatic Brain Injury (TBI) (NCT NCT01847755)

Last Updated: 2021-04-27

Results Overview

This study is designed to test the hypothesis that patients with TBI treated with 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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	120 Hyperbaric Treatments at 1.5 ATA Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. 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.
Overall Study STARTED	18
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	120 Hyperbaric Treatments at 1.5 ATA Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. 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.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Hyperbaric Treatment of Traumatic Brain Injury (TBI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	120 Hyperbaric Treatments at 1.5 ATA n=18 Participants Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment

Outcome measures

Outcome measures
Measure	120 Hyperbaric Treatments at 1.5 ATA n=13 Participants Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. 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.
Number of Participants With Improved Cerebral Perfusion	8 Participants

Adverse Events

120 Hyperbaric Treatments at 1.5 ATA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	120 Hyperbaric Treatments at 1.5 ATA n=18 participants at risk Patient receives 120 treatments of Hyperbaric at 1.5 ATA. Non randomized trial. Pt will have cognitive assessments and Spect scans at various treatment points. Oxygen is at 1.5 atmospheric pressure. 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.
Cardiac disorders Hospitalization	5.6% 1/18 • Approximately 10 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barry Miskin

Jupiter Medical Center

Phone: 561-263-5791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place