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NCT Number: NCT07273292

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

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

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Key information

Conditions

NMO and MS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bedside cardiovascular reflex tests

Diagnostic Test

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

Primary outcomes

Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum Disorder

Time frame: Baseline

Autonomic 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 outcomes

Correlations with disability, MRI findings, fatigue, and quality of life.

Time frame: baseline
D. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Moshref Abd alsattar, Master

CONTACT

[email protected]

0201068960922

Sponsors and collaborators

Lead sponsor

Mohamed Moshref abd alsattar

Other

Registry information

Acronym: English Title

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Dec 9, 2025
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.