Idiopathic Intracranial Hypertension (IIH)IIHNCT06950099
Advanced Neuroimaging in Idiopathic Intracranial Hypertension
An observational study of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH), Glymphatic System
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Refractory IIH patients who require and plan to have a venous sinus stenting
Who may be able to join
- Refractory IIH patients who require and plan to have a venous sinus stenting
Who cannot join
- History of head trauma and shunting or leak repair
- Major concurrent, active non-cephalic pain syndrome
- Contradictions for MRIs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Mary Hopkins, 215-955-2680, mary.hopkins@jefferson.edu
About this study
Official title: Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging
Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.
- Keywords
- idiopathic intracranial hypertension, MRI, diffusion tensor imaging, IIH
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with TSS | Pre- and post-stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced MRI measurements changes pre- and post-stenting
DTI-ALPS index
Measured: 3 months
Secondary outcomes (1)
Clinical headache outcomes
Monthly headache days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start3 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- American Headache Society
- Responsible party
- Sponsor
- Investigators
- Hsiangkuo Yuan, MD PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950099
- Sponsor's protocol ID
- JT44344 fMRI in IIH
- Acronym
- IIH
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging
- ClinicalTrials.gov ID
- NCT06950099
- Acronym / sponsor ID
- IIH / JT44344 fMRI in IIH
- Keywords
- idiopathic intracranial hypertension, MRI, diffusion tensor imaging, IIH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- American Headache Society
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2025 (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.
Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TSS | – | –Pre- and post-stenting |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Refractory IIH patients who require and plan to have a venous sinus stenting
Key inclusion criteria (1 listed)
- Refractory IIH patients who require and plan to have a venous sinus stenting
Key exclusion criteria (3 listed)
- History of head trauma and shunting or leak repair
- Major concurrent, active non-cephalic pain syndrome
- Contradictions for MRIs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advanced MRI measurements changes pre- and post-stenting
Time frame: 3 months
DTI-ALPS index
1 secondary outcome
Clinical headache outcomes
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hsiangkuo Yuan, MD PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Intracranial Hypertension (IIH) and Glymphatic System, run by Thomas Jefferson University at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enchao Qiu, MD PhD (215-955-1149, enchao.qiu@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced MRI measurements changes pre- and post-stenting (time frame: 3 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 2 May 2025.