Hyperbaric Treatment of Traumatic Brain Injury (TBI)

NCT ID: NCT01847755

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2020-12-31

Brief 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.

Detailed Description

Patients with Traumatic Brain Injury (TBI)have abnormal findings including hemorrhagic cortical contusions or petechial or foci of altered signal that represents white matter injury. MRI, CT or SPECT scans showing changes consistent with Traumatic Brain Injury (TBI)and or medical history of Traumatic Brain Injury (TBI)as evidenced by medical records will be screened for treatment with Hyperbaric. Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 atmospheres absolute(ATA).

Each patient will have a SPECT scan, cognitive assessment, and physician evaluation prior to first treatment and after 40, 80, and 120 treatments to document progress of the treatment (Harch et al, 2012). Cognitive assessment will include the Trail Making Test Parts A and B. Patient will be seen by physician to assess level of disability at each interval; the United States Department of Veteran Affairs' Evaluation of Cognitive Impairment and Subjective Symptoms (VAECI) (2012) tool will be utilized during the physician's evaluation as an objective measure of the patient's level of disability.

Hyperbaric treatments may be adjusted for patient comfort. If the SPECT scan, cognitive assessment and physician evaluation show improvement after 40 treatments, another 40 Hyperbaric(HBO)treatments will be administered. Treatments will be discontinued after a 40 session interval if the SPECT scan, cognitive assessment and physician evaluation show no improvement. The patient will also have a SPECT scan and cognitive assessment follow up 3 months after final Hyperbaric(HBO) treatment.The time points for evaluation of cognitive status and single-photon emission computerized tomography (SPECT) scan will be at at 40,80,120 Hyperbaric(HBO)treatments. Treatment will occur 5 times per week for approximately 24 weeks with another follow up 3 months post treatment. This will provide all data points for outcome measure.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxygen at 1.5 ATA (atmospheres absolute).

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

02 or Oxygen

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jupiter Medical Center

OTHER

Sponsor Role: collaborator

Barry Miskin, MD

OTHER

Sponsor Role: lead

Responsible Party

Barry Miskin, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Barry Miskin, MD

Role: PRINCIPAL_INVESTIGATOR

Jupiter Medical Center

Locations

Jupiter Medical Center

Jupiter, Florida, United States

Countries

United States

References

Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.

Reference Type: BACKGROUND

PMID: 22026588 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

117686

Identifier Type: OTHER

Identifier Source: secondary_id

JMC-TBI-001

Identifier Type: -

Identifier Source: org_study_id