Back to resultsHyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery
Primary Purpose
Intracranial Meningioma, Neurologic Deficits
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
HBOT
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Meningioma
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.
Sites / Locations
- Assaf-Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
HBOT
Control/Crossover
Arm Description
Group will be treated with HBOT for 60 treatments in 3 months.
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
Outcomes
Primary Outcome Measures
Neurocognitive functions
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
Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.
Full Information
NCT ID
NCT02084927
First Posted
March 10, 2014
Last Updated
March 10, 2014
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02084927
Brief Title
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery
Official Title
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Meningioma, Neurologic Deficits
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBOT
Arm Type
Experimental
Arm Description
Group will be treated with HBOT for 60 treatments in 3 months.
Arm Title
Control/Crossover
Arm Type
Other
Arm Description
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
Intervention Type
Biological
Intervention Name(s)
HBOT
Intervention Description
HBOT of 2 ATA for 90 minutes, for 60 treatments
Primary Outcome Measure Information:
Title
Neurocognitive functions
Description
Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Hadanny, MD
Phone
972544707381
Email
amir.had@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin,
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery
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