Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Apathy Symptoms
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
- •Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
- •Mini Mental State Examination scores from 10 to 20
- •Apathy defined by a score equal or higher to 14 in Apathy Scale
Exclusion Criteria
- •Clinical instability
- •Metallic clip in the head
- •Use of alcohol and psychotropic drugs
Arms & Interventions
Sham tDCS
sham-tDCS application every 2 days for 2 weeks (total of 6 applications)
Intervention: Transcranial direct current stimulation (Device)
Transcranial direct current stimulation
tDCS application every 2 days for 2 weeks (total of 6 applications)
Intervention: Transcranial direct current stimulation (Device)
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Claudia Kimie Suemoto
Assistant Professor
University of Sao Paulo