NCT02714465

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Niguarda Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Cerebral Necrosis

Interventions

Type	Name	Description
OTHER	hyperbaric oxygen therapy	hyperbaric oxygen therapy

Timeline

• Start date: 2016-03-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2016-03-21
• Last updated: 2023-03-22

Locations

1 site across 1 country: Italy