NCT02084927

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

March 10, 2014

Last Update Submit

March 10, 2014

Conditions

Intracranial MeningiomaNeurologic Deficits

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive functions

    Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.

    6 months

Secondary Outcomes (1)

  • Quality of Life

    6 months

Study Arms (2)

HBOT

EXPERIMENTAL

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

Biological: HBOT

Control/Crossover

OTHER

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

Biological: HBOT

Interventions

HBOTBIOLOGICAL

HBOT of 2 ATA for 90 minutes, for 60 treatments

Control/CrossoverHBOT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

MeningiomaNeurologic Manifestations

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shai Efrati, MD

    Assaf-Harofeh Medical Center

    STUDY CHAIR

Central Study Contacts

Amir Hadanny, MD

CONTACT

972544707381amir.had@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shai Efrati

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2017

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

IL(1)