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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02714465

Acronym

GKSHBO

Enrollment

Registered

2016-03-21

Start date

2016-03-01

Completion date

2023-03-01

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Necrosis

Keywords

Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery

Brief 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

Interventions

OTHERhyperbaric oxygen therapy

hyperbaric oxygen therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026