Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 1

Conditions: Intracranial Meningioma; Neurologic Deficits

Treatments: Biological: HBOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02084927

37/14

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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62 participants in 2 patient groups

HBOT

Experimental group

Description:

Group will be treated with HBOT for 60 treatments in 3 months.

Treatment:

Biological: HBOT

Control/Crossover

Other group

Description:

Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months.

Treatment:

Biological: HBOT