NCT02122042

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

Trial Health

55
Monitor

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

April 22, 2014

Last Update Submit

April 22, 2014

Conditions

Post Low Grade Glioma SurgeryCognitive 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
Also known as: HBOT of 2 ATA for 90 minutes O2 100%, 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, Israel, 70300, Israel

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

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

April 22, 2014

First Posted

April 24, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

IL(1)