Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

NCT ID: NCT02084927

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30

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.

Conditions

Intracranial Meningioma; Neurologic Deficits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HBOT

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

Group Type: EXPERIMENTAL

HBOT

Intervention Type: BIOLOGICAL

HBOT of 2 ATA for 90 minutes, for 60 treatments

Control/Crossover

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

Group Type: OTHER

HBOT

Intervention Type: BIOLOGICAL

HBOT of 2 ATA for 90 minutes, for 60 treatments

Interventions

HBOT

HBOT of 2 ATA for 90 minutes, for 60 treatments

Intervention Type: BIOLOGICAL

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;
• 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

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh MC

Shai Efrati

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shai Efrati, MD

Role: STUDY_CHAIR

Assaf-Harofeh Medical Center

Locations

Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Central Contacts

Amir Hadanny, MD

Role: CONTACT

amir.had@gmail.com

972544707381

Other Identifiers

37/14

Identifier Type: -

Identifier Source: org_study_id