NCT02122042UnknownPhase 1
Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery - Randomized Prospective Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Neurocognitive functions
Study Overview
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 impairment after low grade glioma tumor removal surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HBOT
Experimental
Group will be treated with HBOT for 60 treatments in 3 months.
Intervention: HBOT (Biological)
Control/Crossover
Other
Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
Intervention: HBOT (Biological)
Outcomes
Primary Outcomes
Neurocognitive functions
Time Frame: 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 Outcomes
- Quality of Life(6 months)
Investigators
Assaf Harofeh MC
Shai Efrati
Assaf-Harofeh Medical Center
Study Sites (2)
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