Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

Neurologic Deficits Clinical Trial

Official title:

Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02084927
• Other study ID #: 37/14
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 10, 2014
• Last updated: March 10, 2014
• Start date: April 2014

Study information

• Verified date: March 2014
• Source: Assaf-Harofeh Medical Center
• Contact: Amir Hadanny, MD
• Phone: 972544707381
• Email: amir.had[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intracranial Meningioma
• Meningioma
• Neurologic Deficits

Intervention

Biological:
• HBOT
HBOT of 2 ATA for 90 minutes, for 60 treatments

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zerifin,

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	Quality of Life	Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.	6 months	No