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

NCT ID: NCT02122042

Last Updated: 2014-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Post Low Grade Glioma Surgery Cognitive Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HBOT

Group will be treated with HBOT for 60 treatments in 3 months.

Group Type EXPERIMENTAL

HBOT

Intervention Type BIOLOGICAL

Control/Crossover

Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.

Group Type OTHER

HBOT

Intervention Type BIOLOGICAL

Interventions

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HBOT

Intervention Type BIOLOGICAL

Other Intervention Names

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HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Shai Efrati

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shai Efrati, MD

Role: STUDY_CHAIR

Assaf-Harofeh Medical Center

Locations

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Assaf-Harofeh Medical Center

Ẕerifin, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Amir Hadanny, MD

Role: CONTACT

972544707381

Other Identifiers

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64/14

Identifier Type: -

Identifier Source: org_study_id

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