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

NCT07624812 | Completed

• 2 other identifiers: 21A3032023/PR-Multi/002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

Placebo; Psychology; fatigue

Outcome Measures

Primary Outcomes (1)

• Motor performance

  the overall number of flexions at the motor task

  baseline

Secondary Outcomes (1)

• Readiness Potential

  baseline

Study Arms (2)

Placebo group.

EXPERIMENTAL

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

Natural History Group

NO INTERVENTION

During the rest phase, participants were instructed to relax. Notably, no TENS treatment was administered, and no expectations regarding fatigue reduction were induced

Interventions

TENS therapy BEHAVIORAL

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

Placebo group.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Ospedale San Giuseppe

Piancavallo, Verbanio-Cusio-Ossola, 28824, Italy

Location

Related Publications (1)

• Volpino V, Navarra ME, Scarpina F, Piedimonte A, Scacchi M, Bianchi L, Mauro A, Carlino E. Motor placebo effect in obesity: how ergogenic aids can decrease fatigue and improve motor performance. Eat Weight Disord. 2025 Nov 10;30(1):85. doi: 10.1007/s40519-025-01794-5.

  PMID: 41212312 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Fatigue

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 3, 2026
• Study Start: January 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)