Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy (GKSHBO)

March 21, 2023 updated by: Niguarda Hospital

Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)

Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 10 and 75 years
  • understanding of the Italian language
  • ability to understand the procedures and carrying out of the study
  • signing informed consent for adults and minors in use
  • underwent radiosurgery with clinical and instrumental signs of radiation necrosis

Exclusion Criteria:

  • younger than 10yrs old and older than 75yrs old
  • not capable to understand Italian language or to understand the protocol procedures and visits' scheme
  • informed consent not given
  • enrolled in another clinical trial
  • concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome
  • under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment
  • life expectancy less than 6 months
  • Rankin Scale >5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric oxygen therapy
All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis
Other: hyperbaric oxygen therapy
hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of clinical improvement
Time Frame: day 2 through day 25
By neurological evaluation (Ranking Scale)
day 2 through day 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the reduction of the extent of edema lesion documented by MRI
Time Frame: 1-3 months
MRI analysis
1-3 months
Measurement of complications from hyperbaric oxygen therapy and their severity
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 644-122015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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