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Completed

NCT Number: NCT07624812

Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in RR-MS

To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo.

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Key information

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Giuseppe

Piancavallo, Verbanio-Cusio-Ossola, 28824, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

i) right-hand dominant; ii) diagnosis of MS, Relapsing-Remitting (RR-) form (Polman et al., 2011); iii) score at the EDSS (Kurtzke, 1983) from 2 to 5.5.

Exclusion criteria

i) relapse occurring over the previous six months; ii) a history of illness not less than one year; iii) first dose of disease-modifying or symptomatic treatments and any medication change in the previous three months; iv) reporting a score of equal to 2 or more at FSS (Kurtzke, 1983) cerebellar and brainstem scales; v) neuroimaging evidence of MS lesions at the spinal cord; vi) any known psychiatric or other neurological disorders, history of head injury, or stroke; vii)a score < 24 (Lezak et al., 2004) at the Italian version (Magni et al., 1995) at the MMSE (Folstein et al., 1975).

Treatment and study plan

TENS therapy

Behavioral

A 30-min sham TENS intervention was administered combined with positive verbal suggestions.

Primary outcomes

  1. Motor performance

    Time frame: baseline

    the overall number of flexions at the motor task

Secondary outcomes

  1. Readiness Potential

    Time frame: baseline

    The Readiness Potential (RP) measured by EEG recordings

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Behavioral and Electrophysiological Evidence of the Modulation of Fatigue in Multiple Sclerosis, Relapsing Remitting Form: a Pilot Study

Acronym: Fatigue_SM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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.

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