NMO and MSEnglish TitleNCT07273292
Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study
An observational study of NMO and MS, run by Mohamed Moshref abd alsattar.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMO and MS
- What is being tested?
- Bedside cardiovascular reflex tests
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of neuromyelitis optica spectrum disorders and multiple sclerosis
Who may be able to join
- 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.
Who cannot join
- Comorbidities affecting autonomic function (e.g., diabetes, Parkinsonism).
- Medications known to interfere with autonomic testing.
- Cognitive impairment precluding questionnaire completion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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
- Conditions
- NMO and MS
- Being tested
- Bedside cardiovascular reflex tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside cardiovascular reflex testsDiagnostic test
These tests evaluate both parasympathetic and sympathetic components of cardiovascular regulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum Disorder
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.
Measured: Baseline
Secondary outcomes (1)
Correlations with disability, MRI findings, fatigue, and quality of life.
- 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.
- 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).
- Neuroimaging: Brain and Spinal MRI
- 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for NMO and MSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Moshref abd alsattar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Moshref abd alsattar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273292
- Sponsor's protocol ID
- Autonomics in NMO and MS
- Acronym
- English Title
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 13638541HAMILTON JE, HALL WM, HARBRECHT PJ. Carcinoma of the tongue: its behavior and management. Surgery. 1960 Aug;48:385-90. No abstract available.
PubMed 14399265Pigg 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.
PubMed 29108089Kurtzke 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.
PubMed 6685237Sletten 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.
PubMed 23218087Cohen 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.
PubMed 40652383Pentland B, Ewing DJ. Cardiovascular reflexes in multiple sclerosis. Eur Neurol. 1987;26(1):46-50. doi: 10.1159/000116311.
PubMed 3816885Wingerchuk 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/WNL.0000000000001729. Epub 2015 Jun 19.
PubMed 26092914Frileck S. The work. Plast Reconstr Surg. 2003 Aug;112(2):681-3. doi: 10.1097/01.PRS.0000070942.73903.FD. No abstract available.
PubMed 12900633Crnosija L, Krbot Skoric M, Andabaka M, Junakovic A, Martinovic V, Ivanovic J, Mesaros S, Pekmezovic T, Drulovic J, Habek M. Autonomic dysfunction in people with neuromyelitis optica spectrum disorders. Mult Scler. 2020 May;26(6):688-695. doi: 10.1177/1352458519837703. Epub 2019 Mar 19.
PubMed 30887872Racosta JM, Kimpinski K. Autonomic dysfunction, immune regulation, and multiple sclerosis. Clin Auton Res. 2016 Feb;26(1):23-31. doi: 10.1007/s10286-015-0325-7. Epub 2015 Dec 21.
PubMed 26691635Cortez MM, Nagi Reddy SK, Goodman B, Carter JL, Wingerchuk DM. Autonomic symptom burden is associated with MS-related fatigue and quality of life. Mult Scler Relat Disord. 2015 May;4(3):258-63. doi: 10.1016/j.msard.2015.03.007. Epub 2015 Apr 8.
PubMed 26008943Habek M, Crnosija L, Lovric M, Junakovic A, Krbot Skoric M, Adamec I. Sympathetic cardiovascular and sudomotor functions are frequently affected in early multiple sclerosis. Clin Auton Res. 2016 Dec;26(6):385-393. doi: 10.1007/s10286-016-0370-x. Epub 2016 Jul 22.
PubMed 27448576Jarius S, Wildemann B. The history of neuromyelitis optica. J Neuroinflammation. 2013 Jan 15;10:8. doi: 10.1186/1742-2094-10-8.
PubMed 23320783Noyes K, Weinstock-Guttman B. Impact of diagnosis and early treatment on the course of multiple sclerosis. Am J Manag Care. 2013 Nov;19(17 Suppl):s321-31.
PubMed 24494633
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study
- ClinicalTrials.gov ID
- NCT07273292
- Acronym / sponsor ID
- English Title / Autonomics in NMO and MS
- Conditions
- NMO and MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mohamed Moshref abd alsattarUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of neuromyelitis optica spectrum disorders and multiple sclerosis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Comorbidities affecting autonomic function (e.g., diabetes, Parkinsonism).
- Medications known to interfere with autonomic testing.
- Cognitive impairment precluding questionnaire completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside cardiovascular reflex testsThese tests evaluate both parasympathetic and sympathetic components of cardiovascular regulation. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Correlations with disability, MRI findings, fatigue, and quality of life.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publication: PubMed 13638541BLEWETT 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.
- Results publication: PubMed 14399265HAMILTON JE, HALL WM, HARBRECHT PJ. Carcinoma of the tongue: its behavior and management. Surgery. 1960 Aug;48:385-90. No abstract available.
- Results publication: PubMed 29108089Pigg 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.
- Results publication: PubMed 6685237Kurtzke 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.
- Results publication: PubMed 23218087Sletten 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.
- Results publication: PubMed 40652383Cohen 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.
- Results publication: PubMed 3816885Pentland B, Ewing DJ. Cardiovascular reflexes in multiple sclerosis. Eur Neurol. 1987;26(1):46-50. doi: 10.1159/000116311.
- Results publication: PubMed 26092914Wingerchuk 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/WNL.0000000000001729. Epub 2015 Jun 19.
- Results publication: PubMed 12900633Frileck S. The work. Plast Reconstr Surg. 2003 Aug;112(2):681-3. doi: 10.1097/01.PRS.0000070942.73903.FD. No abstract available.
- Results publication: PubMed 30887872Crnosija L, Krbot Skoric M, Andabaka M, Junakovic A, Martinovic V, Ivanovic J, Mesaros S, Pekmezovic T, Drulovic J, Habek M. Autonomic dysfunction in people with neuromyelitis optica spectrum disorders. Mult Scler. 2020 May;26(6):688-695. doi: 10.1177/1352458519837703. Epub 2019 Mar 19.
- Results publication: PubMed 26691635Racosta JM, Kimpinski K. Autonomic dysfunction, immune regulation, and multiple sclerosis. Clin Auton Res. 2016 Feb;26(1):23-31. doi: 10.1007/s10286-015-0325-7. Epub 2015 Dec 21.
- Results publication: PubMed 26008943Cortez MM, Nagi Reddy SK, Goodman B, Carter JL, Wingerchuk DM. Autonomic symptom burden is associated with MS-related fatigue and quality of life. Mult Scler Relat Disord. 2015 May;4(3):258-63. doi: 10.1016/j.msard.2015.03.007. Epub 2015 Apr 8.
Related trials for NMO and MS
Not yet recruitingObservational study
Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder
MS (Multiple Sclerosis), NMO Spectrum Disorder (NMOSD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of NMO and MS, run by Mohamed Moshref abd alsattar.
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 3 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Moshref Abd alsattar, Master (0201068960922, mohamedmshrf47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum Disorder (time frame: Baseline). 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 NCT07273292, which also lists 15 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 9 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.