Home treatment against fatigue in multiple sclerosis by a personalized, bilateral whole-body somatosensory cortex stimulation.
Mult Scler Relat Disord
; 63: 103813, 2022 Jul.
Article
en En
| MEDLINE
| ID: mdl-35597081
ABSTRACT
BACKGROUND:
Fatigue in multiple sclerosis (MS) is a highly invalidating symptom with no pharmacological efficacious therapies, which furthermore present frequent severe side effects. In two previous randomized controlled trials we observed the efficacy of a personalized neuromodulation treatment consisting of a personalized transcranial Direct Current Stimulation (tDCS) for 15 min per day for 5 days (Faremus).METHODS:
By this medical-device phase II study, we aimed at assessing the feasibility, acceptance, safety and efficacy of Faremus treatment when applied at patients' home. We considered the efficacy as primary outcome assessed by a reduction of fatigue levels measured by Modified Fatigue Impact Scale (mFIS) scored before and after the treatment. Primary outcome determined the sample size estimate. Individual ad-hoc questionnaires quantified the acceptance, safety and side effects during the treatment.RESULTS:
All 15 patients completed the treatment, reporting optimal acceptance and safety on using Faremus at their home without side-effects. The treatment ameliorated fatigue symptoms more than 20% of baseline in 10 out of the 15 patients and of 37% on average, with a corresponding effect size 1.21.CONCLUSIONS:
Faremus personalized electroceutical intervention, a 5-days anodal tDCS over the bilateral whole-body somatosensory cortex, is well accepted and can be feasibly, safely, and efficaciously applied at patients' home, offering a comfortable treatment by reducing the need to travel when fatigue-related symptoms hamper the quality of life.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Estimulación Transcraneal de Corriente Directa
/
Esclerosis Múltiple
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Idioma:
En
Revista:
Mult Scler Relat Disord
Año:
2022
Tipo del documento:
Article