AzTrials
AzTrials

Multiple SclerosisNCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

A study testing quantification of sensory and autonomic small nerve fibers by punch skin biopsy, Cardiovascular Reflexes testing and Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms in people with Multiple Sclerosis, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
quantification of sensory and autonomic small nerve fibers by punch skin biopsy, Cardiovascular Reflexes testing and Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesItaly
Study dates
4 Mar 2021to 30 May 2027
Phase
Interventional
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

Who may be able to join

  • diagnosis of relapsing-remitting and primary progressive multiple sclerosis.

Who cannot join

  • other forms of multiple sclerosis,
  • known other neurological disorders
  • assumption of potentially neurotoxic substances or drugs.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vincenzo Provitera, MD contact

+390824909257

vincenzo.provitera@icsmaugeri.it

Giuseppe Caporaso contact

+390824909645

giuseppe.caporaso@icsmaugeri.it

Italy2 sites, 2 recruiting

  • Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II

    Naples, 80131

    Fiore Manganelli, MD, +0817462666, fiore.manganelli@unina.it

    Rosa Iodice, MD, +39081746266, rosa.iodice@unina.it

    Recruiting

  • ICS Maugeri - IRCCS of Telese Terme

    Telese Terme, Benevento, 82037

    Vincenzo Provitera, MD, +390824909257, vincenzo.provitera@icsmaugeri.it

    Recruiting

Other trials in Italy

About this study

Official title: Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis.

The main questions it aims to answer are:

Read more
  • Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ?
  • Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ?
  • How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ?
  • Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ?

Participants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy.

Researchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.

Being tested
quantification of sensory and autonomic small nerve fibers by punch skin biopsy, Cardiovascular Reflexes testing, Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
Keywords
autonomic nervous system, sensory nervous system, rehabilitation, skin biopsy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quantification of sensory and autonomic small nerve fibers by punch skin biopsyDiagnostic test

    We'll perform a punch skin biopsy of 3mm from thigh, leg and fingertip and we'll quantify peripheral sensory and autonomic nerve fibers.

  • Cardiovascular Reflexes testingDiagnostic test

    Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.

  • Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptomsOther

    We'll characterize patients' symptoms through the administration of clinical scales such as: COMPASS 31 autonomic symptoms scale; Small Fiber Neuropathy Symptom Inventory Questionnaire (SFN-SIQ), the Pain Detect Questionnaire and the Total neuropathy score

Study groups in NCT05748015
Study groupRoleWhat they receive
relapsing-remitting multiple sclerosisActive comparatorPatients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Receives: Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy; Diagnostic Test: Cardiovascular Reflexes testing; Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
primary progressive multiple sclerosisActive comparatorPatients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Receives: Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy; Diagnostic Test: Cardiovascular Reflexes testing; Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular reflex test

    Assessment of Cardiovascular reflex responses to physical challenges.

    Measured: At the recruitment

  2. Sudomotor function test

    Assessment of postganglionic sudomotor function through dynamic sweat test

    Measured: At the recruitment

Secondary outcomes (2)

  1. Quantification of peripheral autonomic nerve fibers

    Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).

    Measured: At the recruitment

  2. Quantification of peripheral sensory nerve fibers

    Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).

    Measured: At the recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start4 Mar 2021
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748015
Sponsor's protocol ID
SBLAB/SM20
Status last verified
Apr 2026
First submitted
26 Jan 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mahoney CJ, Ahmed RM, Huynh W, Tu S, Rohrer JD, Bedlack RS, Hardiman O, Kiernan MC. Pathophysiology and Treatment of Non-motor Dysfunction in Amyotrophic Lateral Sclerosis. CNS Drugs. 2021 May;35(5):483-505. doi: 10.1007/s40263-021-00820-1. Epub 2021 May 15.

    PubMed 33993457

  • Gentile F, Scarlino S, Falzone YM, Lunetta C, Tremolizzo L, Quattrini A, Riva N. The Peripheral Nervous System in Amyotrophic Lateral Sclerosis: Opportunities for Translational Research. Front Neurosci. 2019 Jun 25;13:601. doi: 10.3389/fnins.2019.00601. eCollection 2019.

    PubMed 31293369

  • Weis J, Katona I, Muller-Newen G, Sommer C, Necula G, Hendrich C, Ludolph AC, Sperfeld AD. Small-fiber neuropathy in patients with ALS. Neurology. 2011 Jun 7;76(23):2024-9. doi: 10.1212/WNL.0b013e31821e553a.

    PubMed 21646630

  • Truini A, Biasiotta A, Onesti E, Di Stefano G, Ceccanti M, La Cesa S, Pepe A, Giordano C, Cruccu G, Inghilleri M. Small-fibre neuropathy related to bulbar and spinal-onset in patients with ALS. J Neurol. 2015;262(4):1014-8. doi: 10.1007/s00415-015-7672-0. Epub 2015 Feb 17.

    PubMed 25683764

  • Nolano M, Provitera V, Manganelli F, Iodice R, Caporaso G, Stancanelli A, Marinou K, Lanzillo B, Santoro L, Mora G. Non-motor involvement in amyotrophic lateral sclerosis: new insight from nerve and vessel analysis in skin biopsy. Neuropathol Appl Neurobiol. 2017 Feb;43(2):119-132. doi: 10.1111/nan.12332. Epub 2016 Jul 7.

    PubMed 27288647

  • deCarvalho M, Gromicho M, Andersen P, Grosskreutz J, Kuzma-Kozakiewicz M, Petri S, Uysal H, Pinto S. Peripheral neuropathy in ALS: phenotype association. J Neurol Neurosurg Psychiatry. 2021 Oct;92(10):1133-1134. doi: 10.1136/jnnp-2020-325164. Epub 2020 Dec 28. No abstract available.

    PubMed 33372053

  • Chio A, Mora G, Lauria G. Pain in amyotrophic lateral sclerosis. Lancet Neurol. 2017 Feb;16(2):144-157. doi: 10.1016/S1474-4422(16)30358-1. Epub 2016 Dec 8.

    PubMed 27964824

  • Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.

    PubMed 11464847

Questions about this trial

What is this clinical trial studying?

A study testing quantification of sensory and autonomic small nerve fibers by punch skin biopsy, Cardiovascular Reflexes testing and Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms in people with Multiple Sclerosis, run by Istituti Clinici Scientifici Maugeri SpA at 2 sites in Italy.

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 1 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Vincenzo Provitera, MD (+390824909257, vincenzo.provitera@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular reflex test (time frame: At the recruitment). The study lists 2 primary outcomes in all. 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 NCT05748015, which also lists 8 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 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in