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

NCT04287283 | Active Not Recruiting

• 1 other identifier: 0267-19
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury); Stroke; Fibromyalgia; Aging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HBOT

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

Other: Hyperbaric Oxygen

Interventions

Hyperbaric Oxygen OTHER

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

HBOT

Eligibility Criteria

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

Study Population

Retrospective analysis of patients suffering from chronic neuro-cognitive damage or complaints treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel since 2008 .

You may qualify if:

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

You may not qualify if:

• Patients who were not able to complete two cognitive tests

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

hyperbaric center Asaf harofe medical center

Rishon LeZiyyon, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Fibromyalgia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: January 1, 2008
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

IL (1)