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SUSAC's SyndromeCARESSNCT01481662

Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome

An observational study of SUSAC's Syndrome and Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SUSAC's Syndrome, Encephalopathy, Hearing Loss
What is being tested?
Diffusion tensor magnetic resonance imaging of the brain
Type of treatment
Medical device
How many people
100 participants
Where
1 siteFrance
Study dates
Nov 2011to May 2021
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Hospital BICHAT

    Paris, 75018

    Thomas PAPO, Pr, (1)40258705 ext. +33, thomas.papo@aphp.fr

    Karim SACRE, Pr, karim.sacre@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)

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.

Being tested
Diffusion tensor magnetic resonance imaging of the brain
Keywords
SUSAC's Syndrome, encephalopathy, hearing loss, retinal artery branch occlusions, Diffusion tensor MRI
Medical subject headings
Susac Syndrome, Brain Diseases, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diffusion tensor magnetic resonance imaging of the brainDevice

    Also called Diffusion tensor MRI

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

Study groups in NCT01481662
Study groupRoleWhat they receive
retrospectivecases retrospectively reported the last 20 years
ProspectiveDiffusion tensor magnetic resonance imaging of the brain: new cases prospectively reported
Receives: Device: Diffusion tensor magnetic resonance imaging of the brain

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 year

Secondary outcomes (7)
  1. diffusion MRI

    diffusion MRI results

    Measured: 12 months

  2. serum sample

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

    Measured: day 1

  3. cerebrospinal fluid sample

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

    Measured: day 1

  4. DNA sample

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

    Measured: day 1

  5. RNA sample

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

    Measured: 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

    Measured: 5 years

  7. Peripheral Blood Mononuclear Cell

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

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
Case only
Time perspective
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481662
Sponsor's protocol ID
P081261
Other IDs
AOM09039
Acronym
CARESS
Status last verified
Jun 2017
First submitted
22 Nov 2011
Last updated
21 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Gaudemer A, Henry-Feugeas MC, Peyre M, Kachaner A, Klein I, Khalil A, Papo T, Sacre K. Brain microstructural damage through serial diffusion tensor imaging and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2025 Jan;32(1):e70002. doi: 10.1111/ene.70002.

    PubMed 39686647
  • Kachaner A, Mageau A, Goulenok T, Francois C, Delory N, Chauveheid MP, Laouenan C, Doan S, Halimi C, Klein I, Papo T, Sacre K; French Susac Study Group. Immunosuppressive agents or intravenous immunoglobulin in addition to glucocorticoids in the treatment of Susac syndrome: a French national cohort study. Lancet Rheumatol. 2025 Jan;7(1):e15-e20. doi: 10.1016/S2665-9913(24)00220-0. Epub 2024 Sep 18.

    PubMed 39305913
  • Peyre M, Mageau A, Henry Feugeas MC, Doan S, Halimi C, Klein I, Goulenok T, Francois C, Chauveheid MP, Papo T, Sacre K; French Susac Study Group. Risk factors for severe hearing loss in Susac syndrome: A national cohort study. Eur J Neurol. 2024 May;31(5):e16211. doi: 10.1111/ene.16211. Epub 2024 Jan 18.

    PubMed 38235955
  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of SUSAC's Syndrome and Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2017. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas PAPO, Pr ((1)40258705 ext. +33, thomas.papo@bch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01481662, which also lists 6 linked publications.

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 21 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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