Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

Phase 1

• Conditions: Intracranial Meningioma; Neurologic Deficits
• Interventions: Biological: HBOT

• Registration Number: NCT02084927
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12
• Study Start: 2014-04
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HBOT	HBOT	Group will be treated with HBOT for 60 treatments in 3 months.
Control/Crossover	HBOT	Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.

Primary Outcome Measures

Name	Time	Method
Neurocognitive functions	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

Name	Time	Method
Quality of Life	6 months	Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zerifin,, Israel