MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients

• Conditions: Mild Cognitive Impairment; Hyperbaric Oxygen Therapy
• Interventions: Other: Hyperbaric oxygen therapy

• Registration Number: NCT02452619
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment.

The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

Detailed Description

Retrospective analysis of patients suffering from chronic neuro-cognitive damage due to TBI treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel

Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients are treated with 50-70 daily hyperbaric sessions, 5 days per week. Each session consists of 60 minutes exposure to 100% oxygen at 1.5 ATA.

All patients that underwent MRI before and after HBOT. The MRI protocol included DSC, DCE, DTI, FLAIR, T2 and SWI.

MRI scans sequences parameters:

\* DSC: 50 T2\*-weighted gradient-echo echo planar imaging (EPI) volumes were acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA. Sequence parameters: TR=2,300 ms, TE= 40ms, flip angle = 30°, voxel size = 1.8 x1.8, Matrix = 128x128, No. of slices = 25, Slice thickness = 3.9 mm.

* DCE: three T1 weighted Fast Low Angle SHot (FLASH) volumes were acquired with different flip angles (2, 7 and 15 degrees) followed by 70 dynamic T1 weighted FLASH volumes with flip angle of 15 degrees after bolus injection of Gd-DTPA. Sequence parameters: before injection: TR=4.09, after injection - TR=4.86 ms, TE= 1.76 ms, Voxel size = 1.5x1.5, Matrix = 192X192, No. of slices = 26, Slice thickness = 3.5mm.

* DTI: 30 diffusion weighted images were scanned with different gradient directions (b=1000) and one volume without diffusion weighting, with the following parameters: TR=10,300 ms, TE=89 ms, Voxel size = 1.8X1.8, Matrix = 128 X 128, No. of slices = 63, Slice thickness = 2.2mm

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-23
• Last Update Posted: 2016-10-25
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).

Exclusion Criteria

• did no complete treatment or did not complete examinations.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain trauma	Hyperbaric oxygen therapy	Patients with chronic brain injury that have been treated with Hyperbaric oxygen therapy and underwent MRI imaging and cognitive tests before and after the treatment

Primary Outcome Measures

Name	Time	Method
Microstructure changes (DTI)	Before and after treatment. Treatment is approximately 3 months.
Perfusion MRI changes	Before and after treatment. Treatment is approximately 3 months.

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zerifin, Israel