Non-invasive transcranial cerebellar stimulation: double blind, randomised, sham-controlled study followed by an open label extension phase
Ataxia UK
University of Brescia
Cerebellar transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment which has been demonstrated to modulate cerebellar excitability and improve motor symptoms in patients with neurodegenerative cerebellar ataxias. In a previous study, this group showed that two weeks of tDCS improved symptoms, and this improvement could be seen for up to three months. These researchers now aim to study whether repeating anodal cerebellar tDCS for two weeks, after a three month interval, may prolong clinical improvement, and whether tDCS intervention might improve cerebellar cognitive-affective syndrome (CCAS; Schmahmann's syndrome).  They will perform a double blind, randomised, placebo-controlled study with cerebellar tDCS (5 days/week for 2 weeks; anodal tDCS:placebo tDCS=1:1) in patients with Friedreich's ataxia (FA), spinocerebellar ataxia (SCA), or multiple system atrophy (MSA). Each patient will undergo a clinical evaluation, and cerebellar brain inhibition (CBI) connectivity assessment by Transcranial Magnetic Stimulation at baseline (T0), after tDCS treatment (T1), and at 3-months follow-up (T2). An open-label phase will follow, in which all included patients will receive anodal cerebellar tDCS stimulation (5 days/week for 2 weeks), and will undergo the same standardised assessment after treatment (T3), at 3-months follow-up (T4), at 6-months follow-up (T5), and at 12-months follow up (T6).   They will consider clinical scales as primary outcome measures, and CBI assessment as secondary outcome measures. If the results are positive, tDCS would be envisioned as a promising rehabilitating approach in neurodegenerative ataxias.
6.6 Psychological and behavioural