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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07273292
Acronym
English Title
Enrollment
100
Registered
2025-12-09
Start date
2026-01-20
Completion date
2028-10-31
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NMO and MS

Brief summary

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_TESTBedside cardiovascular reflex tests

These tests evaluate both parasympathetic and sympathetic components of cardiovascular regulation.

Sponsors

Mohamed Moshref abd alsattar
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum DisorderBaselineAutonomic dysfunction assessment using COMPASS-31 questionnaire (Arabic validated version) (12):The Composite Autonomic Symptom Score 31 (COMPASS-31) is a validated, self-administered questionnaire derived from the original 169-item Autonomic Symptom Profile. It provides a concise yet comprehensive evaluation of autonomic symptoms across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. The total weighted score ranges from 0-100, with higher scores reflecting greater autonomic symptom burden.

Secondary

MeasureTime frameDescription
Correlations with disability, MRI findings, fatigue, and quality of life.baselineD. Fatigue and psychiatric symptoms * Fatigue Severity Scale (FSS): Nine-item scale measuring the impact of fatigue on physical, occupational, and social functioning. Widely validated in MS and NMOSD cohorts. * Hamilton Depression Rating Scale (HAM-D)&Hamilton Anxiety Rating Scale (HAM-A): Clinician-administered tools that quantify depression and anxiety severity, respectively. Inclusion is important given the known bidirectional relationship between autonomic dysfunction and mood disorders. E. Quality of life. o The SF-36 is a generic health-related quality of life tool with 36 items covering eight domains (physical functioning, role limitations due to physical/emotional health, pain, vitality, mental health, social functioning, and general health). A. Neuroimaging: Brain and Spinal MRI o MRI will be reviewed for lesion load (number and volume) and lesion topography (anatomical distribution). Assessments will be performed by a neuroradiologist blinded to clinical

Contacts

Primary ContactMohamed Moshref Abd alsattar, Master
mohamedmshrf47@gmail.com0201068960922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026