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

2020 ◽  
Vol 19 (1) ◽  
pp. 327-335
Author(s):  
Galeno Ferreira ◽  
Edson Silva-Filho ◽  
Antônio de Oliveira ◽  
Clemilda de Lucena ◽  
Johnnatas Lopes ◽  
...  
2021 ◽  
Author(s):  
Weiming Sun ◽  
Xing Sun ◽  
Xiangli Dong ◽  
Guohua Yu ◽  
Lang Shuai ◽  
...  

Abstract 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 39–72%. 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 minutes 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), 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 on 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 a relatively small number of participants; thus, the influence of chance on experimental results cannot be completely ruled out. Trial registration number Chinese Clinical Trial Registry,ChiCTR2000031120. Registered on March 22, 2020. This protocol version number is V1.1.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Artur Quintiliano ◽  
Tayanne Oehmen ◽  
Gianna Mastroianni Kirsztajn ◽  
Rodrigo Pegado

Abstract 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.


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