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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy | Experimental | All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen therapy | Other | hyperbaric oxygen therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of clinical improvement | By neurological evaluation (Ranking Scale) | day 2 through day 25 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Lombardy | 20162 | Italy |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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