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Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center Identifier:
First received: March 10, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
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.

Condition Intervention Phase
Intracranial Meningioma
Neurologic Deficits
Biological: HBOT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ]
    Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.

Estimated Enrollment: 62
Study Start Date: April 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBOT
Group will be treated with HBOT for 60 treatments in 3 months.
Biological: HBOT
HBOT of 2 ATA for 90 minutes, for 60 treatments
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
Biological: HBOT
HBOT of 2 ATA for 90 minutes, for 60 treatments


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02084927

Contact: Amir Hadanny, MD 972544707381

Assaf-Harofeh Medical Center Not yet recruiting
Zerifin,, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Study Chair: Shai Efrati, MD Assaf-Harofeh Medical Center
  More Information

Responsible Party: Assaf Harofeh MC, Shai Efrati, Assaf-Harofeh Medical Center Identifier: NCT02084927     History of Changes
Other Study ID Numbers: 37/14
Study First Received: March 10, 2014
Last Updated: March 10, 2014

Additional relevant MeSH terms:
Neurologic Manifestations
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Signs and Symptoms processed this record on May 24, 2017