Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Apathy
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Apathy Symptoms
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Claudia Kimie Suemoto
Assistant Professor
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Apathy Symptoms
Time Frame: Differences in outcome measure comparing second week to baseline
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).