Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research

Active, not recruiting

• Conditions: Fibromyalgia; TBI (Traumatic Brain Injury); Stroke; Aging
• Interventions: Other: Hyperbaric Oxygen

• Registration Number: NCT04287283
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment.

The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.

Detailed Description

Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel

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

Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT

Exclusion Criteria

• Patients who were not able to complete two cognitive tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBOT	Hyperbaric Oxygen	Patients with chronic brain injury or cognitive complaints that have been treated with Hyperbaric oxygen therapy and underwent computerized cognitive tests before and after the treatment

Primary Outcome Measures

Name	Time	Method
Change in neurocognitive scores	baseline and 12 weeks	change in scores in a computerized neuro-cognitive test, "IQ-scale" score, normalized for age and education, with mean=100 and SD=15 points in healthy population, higher score implies better results.

Trial Locations

Locations (1)

hyperbaric center Asaf harofe medical center; 🇮🇱 Rishon lezion, Israel