Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT02084927
First received: March 10, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 30, 2014