Hyperbaric Treatment of Traumatic Brain Injury (TBI)

NCT01847755 | Completed Phase 1 Results DMC

• 2 other identifiers: JMC-TBI-001117686
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved Cerebral Perfusion

  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.

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

Study Arms (1)

120 Hyperbaric treatments at 1.5 ATA

EXPERIMENTAL

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.

Drug: Oxygen at 1.5 ATA (atmospheres absolute).

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.

Also known as: 02 or Oxygen

120 Hyperbaric treatments at 1.5 ATA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Barry Miskin, MD: lead
• Jupiter Medical Center: collaborator

Study Sites (1)

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Related Publications (1)

• 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.

  PMID: 22026588 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Dr. Barry Miskin
• Organization: Jupiter Medical Center

clinicaltrials@jupitermed.com

561-263-5791

Study Officials

• Barry Miskin, MD

  Jupiter Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 27, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-04

Locations

US (1)