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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 1

Conditions: Post Low Grade Glioma Surgery; Cognitive Deficits

Treatments: Biological: HBOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02122042

64/14

Details and patient eligibility

About

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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62 participants in 2 patient groups

HBOT

Experimental group

Description:

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

Treatment:

Biological: HBOT

Control/Crossover

Other group

Description:

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

Treatment:

Biological: HBOT