CClinicalTrials.gg
Status unknownNCT01481662CARESSUpdated Dec 21, 2017

Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome

An observational study in SUSAC's Syndrome, Encephalopathy and Hearing Loss, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.

The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.

Read the detailed description

SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.

The diagnosis of SS is difficult because its characteristic signs often do not occur simultaneously or may be too subtle for the patient to notice. Neurological features of SS may occur several months prior to other symptoms. The retinal artery branch occlusion, by occurring in the peripheral portion of the retina, may remain asymptomatic. Sensorineural hearing loss may also be asymptomatic and disclosed only by audiogram. Besides mild pleocytosis in cerebrospinal fluid, all performed biological tests are virtually negative. No infectious agent, consistent autoimmune marker, or coagulopathy has been disclosed. Changes seen on brain MRI are well characterized although not specific. The only site from which biopsy material is available for pathological analysis is the brain. The most common finding in brain biopsies is the presence of microinfarcts but brain biopsy is not currently performed.

Although the treatment of SS has not been studied in controlled trials, most patients have a good response to treatment with glucocorticoids, with the addition of anti-thrombotic therapy and, for cases in which the disease is refractory to steroids, intravenous immune globulin or cyclophosphamide. The clinical course is characterized by recurrent attacks involving 1 or more components of the triad that characterize the active phase of the disease. Remission usually occurs after the active phase but some patients show residual mild to moderate dementia or gait disturbance, and impaired hearing and vision.

SUSAC's Syndrome is a vasculopathy causing small infarcts in the cochlea, retina and brain. Proposed explanations include a hypercoagulable state, vasospasm, and vasculitis, none of which are supported by laboratory results or findings on brain biopsies. The unique distribution of arteriolar disease affecting the brain, the retina, and the cochlea suggests selective vulnerability of these three structures. The brain, retina, and cochlea all have a blood-tissue barrier, and the endothelium in these sites shares a common embryologic origin and unique structural and antigenic characteristics. It has therefore been proposed that SS is an autoimmune disease in which the endothelium is the primary target, and damage to the endothelium triggers arteriolar occlusion and microinfarcts. However, the pathogenesis remains unknown.

The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, we will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.

Because SUSAC's syndrome is a rare disease, we expect to include one hundred patients in this cohort. The constitution of the cohort and the collection of the samples will last for 2 years and half.

The conclusion of the study, based on statistical analysis done once all patients will be included in the cohort, should allow new recommendations in the diagnosis strategy and give new understandings of the therapeutic management of the disease. The result of this study may also give rise to hypothesis for an interventional study.

It's important to underline that this study must be considered as an interventional study.

Indeed, in this study the patients have a specific MRI, the acquisition of the sequences is with diffusion tensor. While in common practice the patients have only classical MRI without this specific sequences which is the routinely technique used.

02

Conditions studied

  • SUSAC's Syndrome
  • Encephalopathy
  • Hearing Loss
  • Retinal Artery Branch Occlusions

Keywords

  • SUSAC's Syndrome
  • encephalopathy
  • hearing loss
  • retinal artery branch occlusions
  • Diffusion tensor MRI
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 100 is above the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Hundreds of patients with SS, mostly young women, have been reported.

Inclusion criteria

  • Age older than 18
  • Two clinical features of the triad present: encephalopathy, sensorineural hearing loss assessed by audiogram, retinal artery occlusion assessed by fundoscopy or fluorescein retinal angiography.
  • Written informed consent provided. In case of subjects unable to give a written informed consent because of encephalopathy associated with the disease, a written statement of non-opposition should be signed by a relative. This non-opposition statement should be then confirmed by the subject as soon as possible.
  • Realization of a medical examination beforehand

Exclusion criteria

EXCLUSION CRITERIA:

  • Alternative diagnosis: multiple sclerosis, mitochondriopathy, Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL), primary brain tumor, Lyme disease.
  • In case of associated disease (autoimmune disease, tumor, metabolical disease,...), inclusion will need further analysis by the expert comity.
  • Not membership in a national insurance scheme
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
100 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • retrospective

    cases retrospectively reported the last 20 years

  • Prospective

    Diffusion tensor magnetic resonance imaging of the brain: new cases prospectively reported

    Device: Diffusion tensor magnetic resonance imaging of the brain

Interventions

  • DeviceDiffusion tensor magnetic resonance imaging of the brain

    Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease.

    Also known as: Diffusion tensor MRI

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What researchers measure

Primary outcomes

  1. To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome

    To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome

    Time frame: 1 year

Secondary outcomes

  1. diffusion MRI

    diffusion MRI results

    Time frame: 12 months

  2. serum sample

    all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

    Time frame: day 1

  3. cerebrospinal fluid sample

    all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

    Time frame: day 1

  4. DNA sample

    all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

    Time frame: day 1

  5. RNA sample

    all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

    Time frame: day 1

  6. To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome

    To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome

    Time frame: 5 years

  7. Peripheral Blood Mononuclear Cell

    all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

    Time frame: 1 day

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Study locations

1 of 1 sites recruiting
  • Hospital BICHAT
    Paris, 75018, France
    Recruiting
08

References and documents

Publications

  • Scheifer C, Henry Feugeas MC, Roriz M, Cohen Aubart F, Doan S, Jouvent E, Klein I, Machado C, Rouzaud D, Papo T, Sacre K; French Susac Study Group. Brain magnetic resonance imaging lesion load at diagnosis, severity at onset and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2022 Jan;29(1):121-129. doi: 10.1111/ene.15062. Epub 2021 Aug 23. PubMed 34382290 ↗
  • David C, Papo T, Ba I, Ollivier E, Boileau C, Dieude P, Keren B, Kannengiesser C, Sacre K. Hunting for the genetic basis of Susac syndrome. Eur J Neurol. 2021 Jul;28(7):e57-e59. doi: 10.1111/ene.14836. Epub 2021 Apr 7. No abstract available. PubMed 33773011 ↗
  • Machado S, Jouvent E, Klein I, De Guio F, Machado C, Cohen-Aubart F, Sacre K, Papo T. Cognitive dysfunction and brain atrophy in Susac syndrome. J Neurol. 2020 Apr;267(4):994-1003. doi: 10.1007/s00415-019-09664-8. Epub 2019 Dec 11. PubMed 31828475 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01481662
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Nov 29, 2011
Start date
Nov 2011
Primary completion
May 2020 (estimated)
Completion
May 2021 (estimated)
Last update
Dec 21, 2017

Study contacts

Thomas PAPO, Pr
Contact
thomas.papo@bch.aphp.fr
(1)40258705 ext. +33
Fleur Cohen-Aubart, Dr
Contact
fleuraubart@yahoo.fr
(6) 67896079 ext. +33
Thomas PAPO, Pr
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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