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Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

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ClinicalTrials.gov Identifier: NCT02084927
Recruitment Status : Unknown
Verified March 2014 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Intracranial Meningioma Neurologic Deficits Biological: HBOT Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
Study Start Date : April 2014
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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/Crossover
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084927


Contacts
Contact: Amir Hadanny, MD 972544707381 amir.had@gmail.com

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

Responsible Party: Assaf Harofeh MC, Shai Efrati, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02084927     History of Changes
Other Study ID Numbers: 37/14
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Meningioma
Neurologic Manifestations
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Signs and Symptoms