Clinical trial NCT01847755: Hyperbaric Treatment of Traumatic Brain Injury (TBI)
Official title: Phase 1-2 Study of Hyperbaric Treatment of Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Jupiter Medical Center
Sponsor class: OTHER
Collaborators: name: Jupiter Medical Center
First posted: 2013-05-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Improved Cerebral Perfusion
timeFrame: At 120 Hyperbaric Treatments (5 treatments a week) over approximately 24 weeks with a follow up 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
Study officials:
affiliation: Jupiter Medical Center
name: Barry Miskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.