Idiopathic Intracranial HypertensionNCT05308823
Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
A study testing Stent in people with Idiopathic Intracranial Hypertension, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 5 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Grade II paplledema . 2. normal neurological examination except for six nerve palsy. 3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. 4. normal CSF composition. 5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults
Who cannot join
- 1. Age less than to 18 years. 2. creatinine .1.5 mg/dL. 3. severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. 5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 6. pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.
Read the detailed description
Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council.
- They are selected according to The modified Dandy Criteria to Diagnose IIH:
- Grade II paplledema .
- normal neurological examination except for six nerve palsy.
- neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.
- normal CSF composition.
- elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7).
- Exclusion criteria included:
- Age less than orequal to 18 years.
- creatinine .1.5 mg/dL.
- severe allergic reaction to iodine contrast.
- contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.
- dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
- pregnancy.
- Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Stent
- Keywords
- Idiopathic Intracranial Hypertension stenting
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentProcedure or surgery
Also called Venous sinus stenting
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | The paients in this group will receive traditional treatment of IIH for 3 months. |
| Group 2 | Experimental | The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent. Receives: Procedure: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in papillodema
Frisen scale in grading of papilledema evaluation
Measured: 3 months after intervention
Improvement of headache
Headache Impact Test (HIT-6) questionnaire.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start15 Mar 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion5 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alwathekbellah Ihab Ahmed Elsayed, Al-Azhar University
- Investigators
- Mohammed Ahmed Zaki, Ass. Prof, Study director, Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308823
- Sponsor's protocol ID
- 000046
- Status last verified
- Apr 2022
- First submitted
- 11 Feb 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All selected patients will be assessed after 3 months for headache and papilledema by (HIT-6) questionnaire in headache evaluation and Frisen scale in grading of papilledema evaluation in addition to MRV.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT05308823
- Acronym / sponsor ID
- 000046
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- Idiopathic Intracranial Hypertension stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 5 Sep 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- 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 work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.
Detailed description
Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council.
- They are selected according to The modified Dandy Criteria to Diagnose IIH:
- Grade II paplledema .
- normal neurological examination except for six nerve palsy.
- neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.
- normal CSF composition.
- elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7).
- Exclusion criteria included:
- Age less than orequal to 18 years.
- creatinine .1.5 mg/dL.
- severe allergic reaction to iodine contrast.
- contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.
- dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
- pregnancy.
- Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –The paients in this group will receive traditional treatment of IIH for 3 months. |
| Group 2 | Experimental | Procedure: StentThe patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Grade II paplledema . 2. normal neurological examination except for six nerve palsy. 3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. 4. normal CSF composition. 5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults
Key exclusion criteria (1 listed)
- 1. Age less than to 18 years. 2. creatinine .1.5 mg/dL. 3. severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. 5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 6. pregnancy.
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 |
|---|---|---|
| StentAlso: Venous sinus stentingThe patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent | Procedure or surgery | Group 2 |
Primary outcome
Change in papillodema
Time frame: 3 months after intervention
Frisen scale in grading of papilledema evaluation
Improvement of headache
Time frame: 3 months after intervention
Headache Impact Test (HIT-6) questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No. All selected patients will be assessed after 3 months for headache and papilledema by (HIT-6) questionnaire in headache evaluation and Frisen scale in grading of papilledema evaluation in addition to MRV.
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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.
Mohammed Ahmed Zaki, Ass. Prof study director
Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent in people with Idiopathic Intracranial Hypertension, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 1 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 4 Apr 2022. 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 Egypt. 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?
Results are not available in the source record.
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?
Change in papillodema (time frame: 3 months after intervention). The study lists 2 primary outcomes in all. 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 4 Apr 2022.