- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04287283
Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research
The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rishon LeZiyyon, Israel
- hyperbaric center Asaf harofe medical center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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40-60 daily hyperbaric sessions, 5 days per week.
Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in neurocognitive scores
Time Frame: baseline and 12 weeks
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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.
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baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Muscular Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Rheumatic Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Brain Injuries, Traumatic
- Stroke
- Fibromyalgia
- Therapeutics
- Respiratory Therapy
- Oxygen Inhalation Therapy
- Hyperbaric Oxygenation
Other Study ID Numbers
- 0267-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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