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Not yet recruiting NCT07273292

Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study

— Observational NMO and MS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bedside cardiovascular reflex tests.
Who it may be relevant to
Registry conditions: NMO and MS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To compare the frequency and patterns of autonomic dysfunction in patients with NMOSD and MS, and to investigate its correlations with clinical disability, radiological findings, fatigue, and quality of life parameters

Interventions

  • Diagnostic test Bedside cardiovascular reflex tests
    These tests evaluate both parasympathetic and sympathetic components of cardiovascular regulation.

Primary outcome measures

  • Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum Disorder [Time frame: Baseline]
Secondary outcome measures (1)
  • Correlations with disability, MRI findings, fatigue, and quality of life. [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥18 years , both sexes.
  • Confirmed diagnosis of NMOSD according to the 2015 International Consensus Criteria.
  • Confirmed diagnosis of RRMS according to the 2024 McDonald diagnostic criteria.

Exclusion criteria

  • Comorbidities affecting autonomic function (e.g., diabetes, Parkinsonism).
  • Medications known to interfere with autonomic testing.
  • Cognitive impairment precluding questionnaire completion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • BLEWETT J. Manifestations of yaws in Great Britain. Br J Radiol. 1959 Mar;32(375):198-201. doi: 10.1259/0007-1285-32-375-198. No abstract available. PMID 13638541
  • HAMILTON JE, HALL WM, HARBRECHT PJ. Carcinoma of the tongue: its behavior and management. Surgery. 1960 Aug;48:385-90. No abstract available. PMID 14399265
  • Pigg S, Cautley D, Francisco PW. Impacts of weatherization on indoor air quality: A field study of 514 homes. Indoor Air. 2018 Mar;28(2):307-317. doi: 10.1111/ina.12438. Epub 2017 Nov 27. PMID 29108089
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444. PMID 6685237
  • Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012 Dec;87(12):1196-201. doi: 10.1016/j.mayocp.2012.10.013. PMID 23218087
  • Cohen JA. 2024 revision of the McDonald diagnostic criteria for MS: Substantial and substantive changes. Mult Scler. 2025 Oct;31(11):1269-1275. doi: 10.1177/13524585251351860. Epub 2025 Jul 13. No abstract available. PMID 40652383
  • Pentland B, Ewing DJ. Cardiovascular reflexes in multiple sclerosis. Eur Neurol. 1987;26(1):46-50. doi: 10.1159/000116311. PMID 3816885
  • Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, de Seze J, Fujihara K, Greenberg B, Jacob A, Jarius S, Lana-Peixoto M, Levy M, Simon JH, Tenembaum S, Traboulsee AL, Waters P, Wellik KE, Weinshenker BG; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul 14;85(2):177-89. doi: 10.1212 PMID 26092914

Identifiers

NCT: NCT07273292 · Autonomics in NMO and MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗