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

Niguarda Hospital65 enrolled

Overview

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)

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Necrosis

Interventions

hyperbaric oxygen therapyOTHER

hyperbaric oxygen therapy

Eligibility

Sex: ALLMin age: 10 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Outcomes

Primary Outcomes

Evaluation of clinical improvement

By neurological evaluation (Ranking Scale)

Time frame: day 2 through day 25

Secondary Outcomes

Evaluation of the reduction of the extent of edema lesion documented by MRI

MRI analysis

Time frame: 1-3 months

Measurement of complications from hyperbaric oxygen therapy and their severity

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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