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NCT04287283 Clinical Trial

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

Stroke Clinical Trial

Official title:
The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04287283
Other study ID # ASF-19-0267
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2008
Est. completion date December 2025

Study information
Verified date April 2023
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2500
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Hyperbaric Oxygen
40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.

Locations
Country Name City State
Israel hyperbaric center Asaf harofe medical center Rishon lezion

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in neurocognitive scores 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. baseline and 12 weeks
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