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

Primary Purpose

Apathy, Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apathy focused on measuring Apathy, Alzheimer's Disease, Dementia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
  2. 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)
  3. Mini Mental State Examination scores from 10 to 20
  4. Apathy defined by a score equal or higher to 14 in Apathy Scale

Exclusion criteria:

  1. Clinical instability
  2. Epilepsy
  3. Metallic clip in the head
  4. Use of alcohol and psychotropic drugs

Sites / Locations

  • University of São Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham tDCS

Transcranial direct current stimulation

Arm Description

sham-tDCS application every 2 days for 2 weeks (total of 6 applications)

tDCS application every 2 days for 2 weeks (total of 6 applications)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 21, 2011
Last Updated
December 9, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01481558
Brief Title
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease
Official Title
Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy, Alzheimer's Disease
Keywords
Apathy, Alzheimer's Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
sham-tDCS application every 2 days for 2 weeks (total of 6 applications)
Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
tDCS application every 2 days for 2 weeks (total of 6 applications)
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
tDCS 2 mA, dorsolateral pre-frontal cortex
Primary Outcome Measure Information:
Title
Apathy Symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Epilepsy Metallic clip in the head Use of alcohol and psychotropic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ricardo Nitrini, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claudia K Suemoto, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ester Nakamura-Palacios, MD, PhD
Organizational Affiliation
Federal University of Espirito Santo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel Apolinário, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of São Paulo Medical School
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24262299
Citation
Suemoto CK, Apolinario D, Nakamura-Palacios EM, Lopes L, Leite RE, Sales MC, Nitrini R, Brucki SM, Morillo LS, Magaldi RM, Fregni F. Effects of a non-focal plasticity protocol on apathy in moderate Alzheimer's disease: a randomized, double-blind, sham-controlled trial. Brain Stimul. 2014 Mar-Apr;7(2):308-13. doi: 10.1016/j.brs.2013.10.003. Epub 2013 Oct 25.
Results Reference
derived

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

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