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Compares treatment options for Idiopathic Intracranial Hypotension
Official title Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
ClinicalTrials.gov ID: NCT05707442
What this study is testing
What is Acetazolamide-based medical therapy?
Acetazolamide-based medical therapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic intracranial hypotension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Subject Eligibility Criteria
- Diagnosis of IIH by modified Dandy criteria about for more than 2 months
- Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment
- Normal cerebrospinal fluid (CSF) composition
- Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or...
You likely can't join if
- Subject Exclusion Criteria
- Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
- Progressive or rapid visual loss needed urgent surgical intervention; if delay\>24-48 h consider interim lumbar drain (for rapid visual loss...
- Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
- Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
- DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
See the full eligibility criteria
- Subject Eligibility Criteria
- Diagnosis of IIH by modified Dandy criteria about for more than 2 months
- Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment
- Normal cerebrospinal fluid (CSF) composition
- Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI
- Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg
- Patients or their relatives signed written informed consent
- Ophthalmic Eligibility Criteria:
- At least one eye had the presence of papilledema
- At least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15%
- Visual acuity above 20 / 200 (≥ 39 letters)
- Subject Exclusion Criteria
- Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
- Progressive or rapid visual loss needed urgent surgical intervention; if delay\>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath...
- Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)
- Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure
- DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
- A history of severe thyroid disease and iodine allergy
- Pregnant or lactating women
- Severe cardiopulmonary, liver or kidney failure
- Known hereditary or acquired haemorrhagic diathesis
- Known hereditary or acquired thrombophilia
- Platelet counts or coagulation abnormality
- Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
- A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
- Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant...
- Increased intracranial pressure due to other secondary factors
- Ophthalmic Exclusion Criteria:
- Current intraocular pressure \> 28mmHg or previous intraocular pressure \> 30mmHg
- Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:
- Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and...
- Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated...
- Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.