Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial

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

ConditionsIntracranial Meningioma Neurologic Deficits

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Intracranial Meningioma
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 neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

January 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 intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
•All patients have to have persistent cognitive or neurological complaints 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;
•Evidence of dynamic cognitive/neurological improvement in the last month.
•Previous brain radiotherapy and/or radiosurgery.
•Steroids dependence
•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;

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.