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

May 29, 2026 updated by: Federica Scarpina, Istituto Auxologico Italiano

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
    • Verbanio-Cusio-Ossola
      • Piancavallo, Verbanio-Cusio-Ossola, Italy, 28824
        • Ospedale San Giuseppe

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

Accepts Healthy Volunteers

No

Description

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).

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo group.
Participants were told that transcutaneous electrical nerve stimulation (TENS) would be administered to expedite recovery from high exertion. To enhance the credibility of the sham treatment, a somatosensory tactile threshold was recorded beforehand. Two sham electrodes were then placed on the right dorsum of the hand and connected to a stimulator (DS7 Stimulator, Digitimer Ltd). Participants were informed that the device was active at a constant, sub-threshold current, making it imperceptible.
Behavioral: TENS therapy
A 30-min sham TENS intervention was administered combined with positive verbal suggestions.
No Intervention: Natural History Group
During the rest phase, participants were instructed to relax. Notably, no TENS treatment was administered, and no expectations regarding fatigue reduction were induced

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor performance
Time Frame: baseline
the overall number of flexions at the motor task
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readiness Potential
Time Frame: baseline
The Readiness Potential (RP) measured by EEG recordings
baseline

Collaborators and Investigators

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

Sponsor

Istituto Auxologico Italiano

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 (Actual)

January 1, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21A303
  • 2023/PR-Multi/002 (Other Grant/Funding Number: FISM - Fondazione Italiana Sclerosi Multipla)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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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