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. 2019 Dec 30;20(1):805.
doi: 10.1186/s13063-019-3769-6.

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

Artur Quintiliano  1   2 , Tayanne Oehmen  3 , Gianna Mastroianni Kirsztajn  4 , Rodrigo Pegado  5
Affiliations

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

Artur Quintiliano et al. Trials. .

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.

Keywords: Brain stimulation; Depression; Kidney diseases; Pain; Quality of life.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart summarizing the trial. *According to clinical routine, interventions could be performed on Tuesday/Thursday/Saturday. VAS Visual Analogue Scale, M1 motor cortex, DLPFC dorsolateral prefrontal cortex
Fig. 2
Fig. 2
Illustration of electrode replacement. a M1 group. The anodal electrode will be placed over the motor cortex and the cathode over the supra-orbital contralateral area (C3/Fp2 montage). b DLPFC group. The anodal electrode will be placed over the DLPFC and the cathode over the supra-orbital contralateral area (F3/Fp2 montage). Electrodes will the placed according to 10/20 EEG international system. Electrode size 35 cm2 with a current density of 0.057 mA/cm2
Fig. 3
Fig. 3
Schedule of enrollment, interventions, and assessments: Recommendations for Interventional Trials (SPIRIT). VAS Visual Analogue Scale, MPQ McGill Pain Questionnaire, BDI Beck Depression Inventory, HAS Hamilton Anxiety Scale, KDQOL-SF Kidney Disease Quality of Life—Short Form. *Post-intervention evaluation
See this image and copyright information in PMC

References

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