Multiple Sclerosis (MS) - Relapsing-remitting
Conditions
Keywords
Placebo, Psychology, fatigue
Brief summary
To furnish behavioral and electrophysiological evidence of the possible modulation of fatigue in Multiple Sclerosis - relapsing remitting form, through a verbal placebo.
Interventions
BEHAVIORALTENS therapy
A 30-min sham TENS intervention was administered combined with positive verbal suggestions.
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor performance | baseline | the overall number of flexions at the motor task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readiness Potential | baseline | The Readiness Potential (RP) measured by EEG recordings |
Countries
Italy
Outcome results
None listed