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

Assaf-Harofeh Medical Center1 site in 1 country62 target enrollmentMay 2014

ConditionsPost Low Grade Glioma Surgery Cognitive Deficits

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Post Low Grade Glioma Surgery
Sponsor: Assaf-Harofeh Medical Center
Enrollment: 62
Locations: 1
Primary Endpoint: Neurocognitive functions
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

May 2017

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Assaf-Harofeh Medical Center

Responsible Party

Principal Investigator

Assaf Harofeh MC

Shai Efrati

Assaf-Harofeh Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.