Electrical Brain Stimulation and its benefits for Chronic Kidney Patients on Hemodialysis

Not Applicable

• Conditions: Chronic Pain; C12.050.351.968.419.780.750

• Registration Number: RBR-6fgnsqr
• Lead Sponsor: niversidade Federal do Rio Grande do Norte

Brief Summary

Chronic kidney disease (CKD) is an important public health problem. While waiting for a transplant, people present several symptoms, such as pain and mood disorders. To assess the effects of transcranial direct current stimulation (tDCS) in patients affected by CKD over pain, anxiety, and depression. This clinical trial included patients with CKD, who presented chronic pain and underwent hemodialysis for more than three months. There were three assessments: at baseline, after interventions, and seven days after the last intervention (follow-up). Ten non-consecutive sessions of tDCS were performed during 20 min per session with an intensity of 2mA. It was found a significant interaction between group and time on pain (p=0.0005) with significant difference between groups at day 10 (p=0.004) and follow-up (p=0.03) for pain. Also, there was a significant difference between groups p<0.02, partial ?2=0.258 for anxiety. There was a tendency of decrease for depression (p = 0.05). After ten sessions of tDCS over the dorsolateral prefrontal cortex of patients affected by CKD improved pain, anxiety, and depression

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Study Completion: 2022-12-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 75 years; previous medical evaluation with clinical diagnosis of depression; anxiety; chronic pain and pressure lability and being on hemodialysis treatment

Exclusion Criteria

Evidence of any cognitive deficit (senile dementia, Alzheimer's); presence of physical and / or organic difficulties; individuals with severe cardiovascular risk or hemodynamically unstable; history of seizures or epileptic disease; pregnancy; metallic implants in the head or neck and cardiac pacemaker

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected primary outcome 1: Moderate pain improvement verified by a 30% decrease in the visual analog pain scale in patients undergoing hemodialysis with transcranial direct current stimulation (tDCS)<br><br>;Primary outcome found 1: Strong decrease in pain symptoms verified through a 79% decrease in the visual analogue pain scale in patients undergoing hemodialysis with transcranial direct current stimulation (tDCS)

Secondary Outcome Measures

Name	Time	Method
Expected secondary outcome 1: Depression improvement according to moderate (30% of improvement) decrease scores of the Beck depression inventory in patients undergoing hemodialysis with transcranial direct current stimulation (tDCS);Secondary Outcome found 1: Mild decrease (13%) in the symptoms of depression verified through the decrease in the Beck Depression Inventory scores in patients undergoing hemodialysis with transcranial direct current stimulation (ETCC);Expected secondary outcome 2: Improvement of 30% or more in anxiety symptom verified by the reduction of the Hamilton Anxiety Questionnaire in patients undergoing hemodialysis with transcranial direct current stimulation (tDCS);Secondary outcome found 2: Improvement of 23% in the symptom of anxiety verified through the decrease of the scores of the Hamilton Anxiety Questionnaire in patients who undergo hemodialysis with transcranial direct current stimulation (tDCS)