Safety and feasibility of transcranial direct current stimulation in end-stage renal disease patients undergoing hemodialysis: an exploratory study.

INTRODUCTION: Patients with end-stage renal disease often face a challenging routine of hemodialysis, dietary restrictions, and multiple medications, which can affect their hemodynamic function. Home-based, safe, and nonpharmacological approaches such as transcranial direct current stimulation (tDCS) should be combined with conventional treatment. OBJECTIVE: To assess the safety and feasibility of tDCS on blood pressure and heart rate in patients with end-stage renal disease undergoing hemodialysis. METHOD: This is a parallel, randomized, sham-controlled trial. Patients undergoing hemodialysis for more than three months were included. The patients received ten non-consecutive 2mA tDCS sessions on the primary motor cortex . Each session lasted 20 minutes. At baseline and after each of the ten sessions, blood pressure and heart rate of the patients were measured hourly for four hours. RESULTS: Thirty patients were randomized to the active or sham group. The mean difference between the groups was calculated as the mean value of the sham group minus the mean value of the active group. Despite there were no statistical changes for all outcomes considering all 10 sessions, we found differences between groups for systolic -10.93 (-29.1;7.2), diastolic -3.63 (-12.4; 5.1), and mean blood pressure -6.0 (-16.3; 4.2) and hear rate 2.26 (-2.5; 7.1). No serious adverse events were found. The active group showed higher blood pressure values at all points, while heart rate was lower in the active group. CONCLUSION: tDCS is safe and feasible for patients with end-stage renal disease undergoing hemodialysis. Future studies should investigate whether tDCS could potentially induce a hypotensive protective effect during hemodialysis.

Transcranial Direct Current Stimulation (tDCS): Pain Management in End-Stage Renal Disease - Report of an Early Randomized Controlled Trial.

CONTEXT: Chronic pain in end-stage renal disease (ESRD) is an increasingly neglected clinical problem affecting more than 60% of patients. Long-term chronic pain could be associated with brain imbalance in circuits of pain matrix and is associated with poor quality of life (QoL) and mood disturbance. OBJECTIVES: The aim of this study was evaluating the effects of transcranial direct current stimulation (tDCS) on pain, QoL, depression, anxiety and affectivity in ESRD patients undergoing hemodialysis (HD). METHODS: This double-blind, randomized, sham-controlled trial included 30 patients with chronic pain undergoing HD. Participants were allocated to Active tDCS and Sham tDCS and received ten non-consecutive sessions of anodal motor cortex stimulation (M1/Sp2 montage) at 2 mA intensity for 20 min. The primary outcome was pain assessed using numeric rating scale (NRS) and collected at baseline, immediately after the 10th day of intervention, one week, two weeks, and four weeks after the last stimulation. Secondary outcomes included QoL, depression, anxiety and affectivity collected before and after intervention. RESULTS: A mixed ANOVA model showed significant interaction between group and time on pain F(4.112) = 3.106, P = 0.01 with main effects of group (P = 0.03). Before and after intervention, a significant improvement was observed in QoL (P = 0.009), general health (P = 0.03), fatigue (P = 0.05), symptoms (P = 0.05) depression (P = 0.01) and anxiety (P = 0.01). No difference was found for affectivity. CONCLUSION: Anodal tDCS over the motor cortex emerges as a potential therapeutic approach for improving pain, QoL, and mood in patients with ESRD.

Transcranial direct current stimulation in management of pain, mood, functionality, and quality of life in patients undergoing hemodialysis: a study protocol for a double-blind controlled randomized trial.

BACKGROUND: Persistent pain can lead to incapacitation requiring long-term pharmacological treatment. Up to 82% of chronic kidney disease (CKD) patients undergoing hemodialysis (HD) have chronic pain and most do not respond to usual medication. Advances in non-pharmacological treatments are necessary to promote pain relief without side effects and to restore functionality. Transcranial direct current stimulation (tDCS) promises to be a novel, cost-efficient, non-pharmacological treatment for CKD patients with chronic pain. In this study, we hypothesize that tDCS could improve pain, depression, functionality, and quality of life in patients with CKD undergoing HD. METHODS/DESIGN: We describe a single-center, parallel-design, double blind randomized, sham-controlled trial. Forty-five subjects with CKD undergoing HD will be randomized to a motor cortex (M1), a dorso lateral prefrontal cortex (DLPFC), or a sham group. A total of ten sessions will be administered to participants over 4 weeks using a monophasic continuous current with an intensity of 2 mA for 20 min. Participants will be evaluated at baseline, immediately after the tenth session, and at 1 week and 4 weeks of follow-up after the intervention. Pain, depression, functionality, and quality of life will be evaluated. DISCUSSION: The results from this study will provide initial clinical evidence on the efficacy and safety of tDCS in patients with CKD undergoing HD. TRIAL REGISTRATION: Brazilian Clinical Trials Registry/Registro Brasileiro de Ensaios Clínicos (ensaiosclinicos.gov.br), 1111-1216-0137. Registered on 20 June 2018.