Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery

Cognitive Deficits Clinical Trial

Official title:

Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery - Randomized Prospective Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02122042
• Other study ID #: 64/14
• Status: Not yet recruiting
• Phase: Phase 1
• First received: April 22, 2014
• Last updated: April 22, 2014
• Start date: May 2014

Study information

• Verified date: April 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 impairment after low grade glioma tumor removal surgery

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Post low grade glioma (WHO I-II) removal surgery 3-12 months prior to the inclusion in the study.

• All patients have to have persistent cognitive impairment (Mindstream score should be at least one SD lower than average) 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; Previous brain radiotherapy and/or radiosurgery. Steroids dependence Chemotherapy in the past month or scheduled in the next 3 months 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

• Cognition Disorders
• Cognitive Deficits
• Glioma
• Post Low Grade Glioma Surgery

Intervention

Biological:
• HBOT

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,SS-QOL ? SF36 , QLQ-BN20, questionnaires at baseline , 3 months and 6 months to intervention.	6 months	No