Fatigue relief in multiple sclerosis by personalized neuromodulation: A multicenter pilot study [FaremusGE]

Abstract

Background: A recent application of the GRADE guidelines indicated Faremus, a 5-day neuromodulation for 15 min per day via transcranial direct current stimulation (tDCS), as medium to highly recommendable for alleviating fatigue in multiple sclerosis (MS).

Methods: With this pilot study we aimed to evaluate the feasibility, acceptance, safety, and effectiveness of the Faremus treatment carried out in a multicenter context. The Rome unit prepared the intervention, supplied the personalized electrodes to the San Martino Hospital in Genova, where the neurological team enrolled the population of fatigued people with multiple sclerosis (PwMS) and carried out the treatment.

Results: All 17 enrolled patients completed treatment, reporting optimal acceptance and safety when using Faremus in the multicenter setting. The team involved, including neurologists, neurophysiopathology technicians, engineers, physicists, and psychologists expressed high appreciation (average score 8 out of 10). The treatment improved fatigue symptoms by an average of 27%, to levels comparable with previous studies. Similarly, mild depressive symptoms improved by an average of 38%.

Conclusions: The Faremus personalized electroceutical intervention, a 5-day anodal tDCS over bilateral whole-body somatosensory cortex with occipital cathode, is well accepted and can be applied feasibly, safely and effectively in a multicenter setting, offering a reliable tool to relieve fatigue-related symptoms, thus supporting the quality of life of fatigued people with MS. The present study lays a starting point for the involvement of multiple MS units nationwide in offering therapeutic enrichment for their fatigued patients.

Keywords: Depression; Fatigue; Neuromodulation; Non-invasive brain stimulation (NIBS); Personalization; Transcranial electric stimulation (tES).