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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122042

Enrollment

Registered

2014-04-24

Start date

2014-05-31

Completion date

Unknown

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Low Grade Glioma Surgery, Cognitive Deficits

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

Interventions

BIOLOGICALHBOT

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Quality of Life	6 months	Quality of live will be evaluated by the EQ-5D,SS-QOL ו SF36 , QLQ-BN20, questionnaires at baseline , 3 months and 6 months to intervention.

Countries

Israel

Contacts

Primary ContactAmir Hadanny, MD

amir.had@gmail.com972544707381

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026