This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.
Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex (DLPFC). Patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. Clinical raters, patients, and caregivers were blinded. The primary outcome was apathy. Global cognition and neuropsychiatric symptoms were examined as secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
tDCS 2 mA, dorsolateral pre-frontal cortex
University of São Paulo Medical School
São Paulo, São Paulo, Brazil
Apathy Symptoms
Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).
Time frame: Differences in outcome measure comparing second week to baseline
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