MR Lymphatic Imaging in Idiopathic Intracranial Hypertention

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a rare condition called idiopathic intracranial hypertension (IIH), where pressure inside the skull becomes too high, causing severe headaches and potential vision problems. The researchers want to learn more about the role of lymphatic vessels in the outer layer of the brain, which may play a part in how IIH develops and progresses. They believe that these lymphatic vessels could be linked to issues with blood flow and fluid retention in the brain. To explore this further, they will use a special imaging technology to look closely at the lymphatic and blood vessels in patients with IIH compared to healthy individuals.

To participate in this trial, women aged 18 to 40 who have been diagnosed with IIH or are healthy volunteers without a history of neurological conditions can apply. Participants will undergo MRI scans to help researchers see any differences in the lymphatic and blood vessel structures. It's important to note that participants should not have any previous surgeries on their brain, certain medical implants, or conditions that would make an MRI unsafe. This study aims to provide better understanding and potentially improve treatments for IIH in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * For all participants:
• • Age \> 18 years and ≤ 40 years female gender Absence of previous neurosurgical or endovascular neurological history Participant able to express her consent Medical insurance
• • For participants with IIH No required criterion of severity or evolution of IIH Definite diagnosis of IIH according to Dandy's modified criteria. All of the following criteria must be met and verified by medical reports or certificates from a neurologist, especially the value of the CSF opening pressure measured during the lumbar puncture must be clearly noted on the reports
• • History of papilledema
• • Normal neurological examination, except for paralysis of the VIth cranial nerve
• • Neuroimaging: normal cerebral parenchyma without hydrocephalus, intracranial expansive process, or structural anomaly, and absence of meningeal contrast enhancement in MRI without and with contrast product. A venous angio-MRI is necessary in atypical patients; if MRI is unavailable or contraindicated, a brain scan without and with contrast product can be done in combination with a venous angioscan with contrast injection
• • Normal CSF composition
• • High CSF opening pressure (≥ 25 cm of water) obtained from a lumbar puncture performed in lateral decubitus
• • For healthy volunteers No previous history of neurological or neurosurgical disorder
• Exclusion Criteria:
• • For all participants Pregnant or breastfeeding woman Contraindication to cerebral MRI: metallic implant, pacemaker, artificial heart valve, cerebral vascular malformation, aneurysm clips, metallic fragments, artificial implants, peripheral or neural pacemaker, insulin pump, intravenous catheter, epilepsy , metallic contraceptive device, claustrophobia, refusal to be informed in case of abnormal MRI (with a significant medical abnormality) Hypersensitivity to the active substance of the contrast agent or to any of the excipients (Sodium calcobutrol, Trometamol, 1N hydrochloric acid (pH adjustment), Water for injections) lumbar puncture in the month preceding the brain MRI Neurological tumoral, degenerative, vascular, inflammatory or progressive pathology Renal or hepatic impairment MRI with gadolinium injection performed in the 7 days preceding the inclusion visit Person subject to a measure of legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty by judicial or administrative decision
• • For participants with IIH Participants with a probable but not definite diagnosis of IIH according to the Dandy modified criteria
• • For healthy volunteers Chronic headaches (\>15 days per month) Uncorrected and/or unlabeled visual symptoms (visual blurriness, diplopia, visual eclipses, papilledema, optic atrophy)