Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study (English Title)

December 7, 2025 updated by: Mohamed Moshref abd alsattar
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of neuromyelitis optica spectrum disorders and multiple sclerosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Moshref abd alsattar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Autonomics in NMO and MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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