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

Study Overview
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Brief Summary
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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)

Detailed Description
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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

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

Conditions
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Cerebral Necrosis

Intervention / Treatment
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* Other: hyperbaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical improvement | 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 | MRI analysis | 1-3 months | 
| Measurement of complications from hyperbaric oxygen therapy and their severity |  | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery