Transcranial direct current stimulation improves quality of life and physical fitness in diabetic polyneuropathy: a pilot double blind randomized controlled trial

Diabetes Mellitus (DM) is a chronic disease which presents a big prevalence in the world and several patients with this condition fail to respond to the available treatments. There is a huge unmet clinical need for the development of new therapeutic approaches for this condition. This study aims to evaluate the effects of anodal tDCS on Quality of Life and physical fitness in patients with diabetic polyneuropathy. A pilot, parallel, sham, randomized, double-blind trial was conducted with twenty patients. Five consecutive sessions of C3/Fp2 tDCS montage were performed. To assess the primary outcome Short Form 36 Health Survey (SF-36) was used. Physical fitness level, according to lower and upper body strength, flexibility, Time Up and Go Test (TUG) and Six-Minute Walking Test (6MWT) were measured as secondary outcomes. The measures were performed at 3 different times (baseline, 1st and 2nd weeks). SF-36 increased throughout the protocol, but no difference between groups were found. However, there was a significant difference between groups at 1st and 2nd weeks, which shows a permanent growth in the active-tDCS group. Physical health and functioning, functional capacity and bodily pain showed significant improvements in active-tDCS group in 1st and 2nd weeks during inter-group analysis. Emotional scores showed significant interaction group-time with interaction effects only for active-group in 1st and 2nd weeks. TUG and 6MWT showed significant improvements only in active-tDCS group. It is suggested that five sessions of anodal M1 tDCS improves QoL and functionality of patients with diabetic polyneuropathy.