Idiopathic Intracranial Hypotension, Venous Sinus Stenosis
Conditions
Keywords
Idiopathic intracranial hypertension, Venous sinus stenosis, Stenting, Medical therapy, Randomized controlled trial
Brief summary
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
Detailed description
The SIMPLE is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 74 patients with idiopathic intracranial hypertension (IIH) and venous sinus stenosis (VSS) for more than 2 months will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (stenting or medical therapy) after offering informed content.
Interventions
PROCEDUREStent Implantation
Aspirin (100 mg) and clopidogrel (75 mg) were administered 3-5 days before endovascular treatment. The endovascular procedure was performed under general anesthesia. Intravenous heparin was administered during the stent procedure to increase the activated clotting time to \> 250 s. An 8F guiding catheter was delivered to the internal jugular vein near the skull base. A 6F Navien intermediate guide catheter was then placed into the distal transverse sinus near the torcula through the 8F guiding catheter. A microguidewire was navigated across the stenosis using a microcatheter, followed by the deployment of a self-expanding stent (eg, Precise or Wallstent) adjusted to the normal sinus venous diameter adjacent to the stenosis. Venography and manometry were performed after the procedure. Postoperatively, all patients received dual antiplatelet medications for 3 months and then received a single antiplatelet (either aspirin or clopidogrel).
DRUGAcetazolamide-based medical therapy
The medical treatment consisted of acetazolamide (0.5-4 g/day) and short-term mannitol (bolus of 0.25-1 g/kg body weight) for a duration of about 1 week or repeated lumbar punctures to reduce intracranial pressure (20 mL each), as well as analgesics for headaches. The initial dosage of acetazolamide was 0.5 g daily in two divided doses, followed by dosage increases of one tablet every week up to a maximum dosage of 4 g/day. The dosage escalation was stopped if the participant had papilledema grade \<1 in both eyes, unless the presence of other symptoms such as headache or tinnitus suggested that the dosage escalation should continue. The dosage for the participants who were unable to tolerate the study drug was decreased gradually to a minimum of one half tablet daily.
BEHAVIORALWeight loss
The weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subject Eligibility Criteria 1. Diagnosis of IIH by modified Dandy criteria about for more than 2 months 2. Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment 3. Normal cerebrospinal fluid (CSF) composition 4. Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI 5. Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg 6. Patients or their relatives signed written informed consent * Ophthalmic Eligibility Criteria: 1. At least one eye had the presence of papilledema 2. 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% 3. Visual acuity above 20 / 200 (≥ 39 letters)
Exclusion criteria
* Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perimetric Mean Deviation (PMD) | 6 months | The change in perimetric mean deviation (PMD) from baseline to 6 month in the eye with the most severe visual loss at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebrospinal Fluid (CSF) Opening Pressure | 6 months | The change in intracranial pressure measured by lumbar puncture opening pressure from baseline to 6 months. |
| Papilledema Grade: Frisén grade(0-5 scores,and higher scores mean worse outcome) | 6 months | The change in papilledema measured by Frisén grade from baseline to 6 months |
| Retinal Nerve Fiber Layer Thickness | 6 months | The change in thickness of retinal nerve fiber layer measured by optical coherence tomography (OCT) from baseline to 6 months. |
| Total Retinal Thickness | 6 months | The change in thickness of total retina measured by optical coherence tomography (OCT) from baseline to 6 months. |
| Visual Acuity: National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25, minimum and maximum values: 0-100 points, higher scores mean a better visual function) | 6 months | The change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) from baseline to 6 months. |
| Visual Acuity: 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) (minimum and maximum values: 0-100 points, higher scores mean a better visual function) | 6 months | The change in vision measured by 10-item neuro-ophthalmic supplement to the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)from baseline to 6 months. |
| Headache: Headache Impact Test-6 (HIT-6, minimum and maximum values: 36-78 points, higher scores mean greater headache severity) | 6 months | The change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline to 6 months. |
| Pulsatile tinnitus: Tinnitus Handicap Inventory (THI, minimum and maximum values: 0-100 points, higher scores mean more serious tinnitus disability) | 6 months | The change in pulsatile tinnitus from baseline to 6 months；pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living. |
Countries
China
Contacts
CONTACTXu Tong, MD
PRINCIPAL_INVESTIGATORDapeng Mo, MD
Beijing Tiantan Hospital
PRINCIPAL_INVESTIGATORZhongrong Miao, MD
Beijing Tiantan Hospital
Outcome results
None listed