Cerebral NecrosisGKSHBONCT02714465
Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
A study testing hyperbaric oxygen therapy in people with Cerebral Necrosis, run by Niguarda Hospital at 1 site in Italy.
Trial 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) Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Cerebral Necrosis
- What is being tested?
- hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2016to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)
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)
Read the 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
- Being tested
- hyperbaric oxygen therapy
- Keywords
- Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyOther
hyperbaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis Receives: Other: hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical improvement
By neurological evaluation (Ranking Scale)
Measured: day 2 through day 25
Secondary outcomes (2)
Evaluation of the reduction of the extent of edema lesion documented by MRI
MRI analysis
Measured: 1-3 months
Measurement of complications from hyperbaric oxygen therapy and their severity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714465
- Sponsor's protocol ID
- 644-122015
- Acronym
- GKSHBO
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)
- ClinicalTrials.gov ID
- NCT02714465
- Acronym / sponsor ID
- GKSHBO / 644-122015
- Conditions
- Cerebral Necrosis
- Keywords
- Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Other: hyperbaric oxygen therapyAll patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyhyperbaric oxygen therapy | Other | Hyperbaric oxygen therapy |
Primary outcome
Evaluation of clinical improvement
Time frame: day 2 through day 25
By neurological evaluation (Ranking Scale)
2 secondary outcomes
Evaluation of the reduction of the extent of edema lesion documented by MRI
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy in people with Cerebral Necrosis, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical improvement (time frame: day 2 through day 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.