Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease

Phase 2

Completed

• Conditions: Apathy; Alzheimer's Disease
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT01481558
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-03-20
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-09
• Last Update Submitted: 2013-12-09
• Results First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Transcranial direct current stimulation	sham-tDCS application every 2 days for 2 weeks (total of 6 applications)
Transcranial direct current stimulation	Transcranial direct current stimulation	tDCS application every 2 days for 2 weeks (total of 6 applications)

Primary Outcome Measures

Name	Time	Method
Apathy Symptoms	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).

Trial Locations

Locations (1)

University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil