Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery

April 22, 2014 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery - Randomized Prospective Trial

The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low grade glioma tumor removal surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post low grade glioma (WHO I-II) removal surgery 3-12 months prior to the inclusion in the study.
  • All patients have to have persistent cognitive impairment (Mindstream score should be at least one SD lower than average) regarding without noticeable improvement during the last month prior to their enrolment.
  • Age 18 years or older.

Exclusion Criteria:

  • Dynamic neurologic/cognitive improvement or worsening during the past month; Previous brain radiotherapy and/or radiosurgery. Steroids dependence Chemotherapy in the past month or scheduled in the next 3 months Seizures 1 month previous to inclusion Had been treated with HBOT for any other reason 1 month prior to inclusion; Have any other indication for HBOT; Chest pathology incompatible with pressure changes; Inner ear disease; Patients suffering from claustrophobia; Inability to sign written informed consent; Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBOT
Group will be treated with HBOT for 60 treatments in 3 months.
Biological: HBOT
Other Names:
  • HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
Other: Control/Crossover
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
Biological: HBOT
Other Names:
  • HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive functions
Time Frame: 6 months
Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 6 months
Quality of live will be evaluated by the EQ-5D,SS-QOL ו SF36 , QLQ-BN20, questionnaires at baseline , 3 months and 6 months to intervention.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Chair: Shai Efrati, MD, Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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