Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084927

Enrollment

Registered

2014-03-12

Start date

2014-04-30

Completion date

Unknown

Last updated

2014-03-12

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

Conditions

Intracranial Meningioma, Neurologic 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 neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.

Interventions

BIOLOGICALHBOT

HBOT of 2 ATA for 90 minutes, for 60 treatments

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 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.

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 questionnaire 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