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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/PR-Multi/002 | Other Grant/Funding Number | FISM - Fondazione Italiana Sclerosi Multipla |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS therapy | Behavioral | A 30-min sham TENS intervention was administered combined with positive verbal suggestions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Motor performance | the overall number of flexions at the motor task | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness Potential | The Readiness Potential (RP) measured by EEG recordings | baseline |
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Giuseppe | Piancavallo | Verbanio-Cusio-Ossola | 28824 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41212312 | Background | 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. |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |