Effects of transcranial direct current stimulation on patients with post-stroke fatigue: a study protocol for a double-blind randomized controlled trial

INTRODUCTION: Post-stroke fatigue (PSF) is an abnormal, persistent, and unexplained physical and psychological tiredness in patients after stroke. It is a common symptom of stroke patients with poor quality of life and bleak prognosis, and the incidence rate is up to 39% to 72%. It has been widely reported that medicine treatments achieved a lot of progress, there still needs to develop more powerful new strategies to more powerful effect. The transcranial direct-current stimulation (tDCS) shows great potential for the treatment of PSF. This study proposes to apply a double-blind randomized controlled clinical trial to explore the effect and safety of tDCS combined with routine rehabilitation for PSF. METHODS AND ANALYSIS: One hundred patients with PSF will be randomly divided into two groups. One of the groups will receive conventional rehabilitation therapy and active tDCS, whereas another group will receive conventional rehabilitation treatment and sham tDCS. Both groups will receive the intervention for 4 weeks, during which time they will undergo either active or sham tDCS 20 min a day, 6 days a week. Primary outcome: Fatigue Severity Scale (FSS) will be measured at baseline every weekend during the intervention period. Secondary results: Fatigue Impact Scale (FIS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), and Specialized Quality of Life Scale in Stroke (SS-QOL) will be measured at baseline and at the end of the intervention time of 4 weeks. Throughout the study, adverse events and adverse reactions will be measured during every treatment. The research study “Effects of transcranial direct current stimulation on patients with post-stroke fatigue” has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University: Clinical Medicine Ethics Review [2015]043 in Nov 2015. DISCUSSION: This study will provide insight into the efficacy of transcranial direct-current stimulation for post-stroke fatigue. This is a double-blind randomized controlled trial whose aim is to assess the effects of tDCS on PSF. This study can provide more information about the treatment of PSF. This study has a period of follow-up, which allows for greater accuracy. It is a single-center trial, and this may be a limitation. The other limitation of this study is the relatively small number of participants; thus, the influence of chance on experimental results cannot be completely ruled out. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000031120. Registered on March 22, 2020. This protocol version number is V1.1.