Intracranial MeningiomaPhase 1NCT02084927
Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery
A Phase 1 study testing HBOT in people with Intracranial Meningioma and Neurologic Deficits, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Meningioma, Neurologic Deficits
- What is being tested?
- HBOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Jan 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
- All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
- Age 18 years or older.
Who cannot join
- Dynamic neurologic/cognitive improvement or worsening during the past month;
- Evidence of dynamic cognitive/neurological improvement in the last month.
- Previous brain radiotherapy and/or radiosurgery.
- Steroids dependence
- Seizures 1 month previous to inclusion
- Had been treated with HBOT for any other reason 1 month prior to inclusion;
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- Have any other indication for HBOT;
- Chest pathology incompatible with pressure changes;
- Inner ear disease;
- Patients suffering from claustrophobia;
- Inability to sign written informed consent;
- Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.
- Conditions
- Intracranial Meningioma, Neurologic Deficits
- Being tested
- HBOT
- Medical subject headings
- Meningioma, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOTBiological
HBOT of 2 ATA for 90 minutes, for 60 treatments
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Experimental | Group will be treated with HBOT for 60 treatments in 3 months. Receives: Biological: HBOT |
| Control/Crossover | Other | Control for 3 months without treatment, and then HBOT for 60 treatments in 3 months. Receives: Biological: HBOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive functions
Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.
Measured: 6 months
Secondary outcomes (1)
Quality of Life
Quality of live will be evaluated by the EQ-5D questionnaire at baseline , 3 months and 6 months to intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial MeningiomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Shai Efrati, MD, Study chair, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084927
- Sponsor's protocol ID
- 37/14
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy Can Improve Neurological State Post Meningioma Removal Surgery -Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT02084927
- Acronym / sponsor ID
- 37/14
- Conditions
- Intracranial Meningioma, Neurologic Deficits
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Jan 2017 (estimated)
- First posted
- 12 Mar 2014 (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.
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT | Experimental | Biological: HBOTGroup will be treated with HBOT for 60 treatments in 3 months. |
| Control/Crossover | Other | Biological: HBOTControl for 3 months without treatment, and then HBOT for 60 treatments in 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post intracranial meningioma removal surgery 3-12 months prior to the inclusion in the study.
- All patients have to have persistent cognitive or neurological complaints regarding without noticeable improvement during the last month prior to their enrolment.
- Age 18 years or older.
Key exclusion criteria (12 listed)
- Dynamic neurologic/cognitive improvement or worsening during the past month;
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 |
|---|---|---|
| HBOTHBOT of 2 ATA for 90 minutes, for 60 treatments | Biological | Control/Crossover, HBOT |
Primary outcome
Neurocognitive functions
Time frame: 6 months
Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention.
1 secondary outcome
Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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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.
Shai Efrati, MD study chair
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBOT in people with Intracranial Meningioma and Neurologic Deficits, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Mar 2014. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Hadanny, MD (972544707381, amir.had@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive functions (time frame: 6 months). 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 12 Mar 2014.