TY - JOUR
T1 - Home treatment against fatigue in multiple sclerosis by a personalized, bilateral whole-body somatosensory cortex stimulation
AU - Tecchio, Franca
AU - Cancelli, Andrea
AU - Pizzichino, Arianna
AU - L'Abbate, Teresa
AU - Gianni, Eugenia
AU - Bertoli, Massimo
AU - Paulon, Luca
AU - Zannino, Silvana
AU - Giordani, Alessandro
AU - Lupoi, Domenico
AU - Pasqualetti, Patrizio
AU - Mirabella, Massimiliano
AU - Filippi, Maria Maddalena
PY - 2022
Y1 - 2022
N2 - 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.
Keywords: Non-invasive brain stimulation (NIBS); neuromodulation; personalization; telemedicine; transcranial electric stimulation (tES).
AB - 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.
Keywords: Non-invasive brain stimulation (NIBS); neuromodulation; personalization; telemedicine; transcranial electric stimulation (tES).
KW - Non-invasive brain stimulation (NIBS)
KW - neuromodulation
KW - personalization
KW - telemedicine
KW - transcranial electric stimulation (tES)
KW - Non-invasive brain stimulation (NIBS)
KW - neuromodulation
KW - personalization
KW - telemedicine
KW - transcranial electric stimulation (tES)
UR - http://hdl.handle.net/10807/207841
U2 - 10.1016/j.msard.2022.103813
DO - 10.1016/j.msard.2022.103813
M3 - Article
SN - 2211-0348
VL - 63
SP - 103813-N/A
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
ER -