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

Study Overview
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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

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

Conditions
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Post Low Grade Glioma Surgery, Cognitive Deficits

Intervention / Treatment
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* Biological: HBOT


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBOT<br>Group will be treated with HBOT for 60 treatments in 3 months. | Biological: HBOT<br> <br> * Other names: HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments;|
| Other: Control/Crossover<br>Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months. | Biological: HBOT<br> <br> * Other names: HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive functions | 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 | 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 |