Clinical trial · Interventional
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
NCT02084927CI-TRIAL-00013998unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Meningioma | Intracranial Meningioma | ONTOLOGY_EXACT | 0.98 |
| Neurologic Deficits | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HBOT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HBOT
- description
- Group will be treated with HBOT for 60 treatments in 3 months.
- interventionNames
- Biological: HBOT
- type
- OTHER
- label
- Control/Crossover
- description
- Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.
- interventionNames
- Biological: HBOT
Primary outcomes (1)
- measure
- Neurocognitive functions
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.