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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Kimie Suemoto, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01481558
First received: November 21, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Apathy
Alzheimer's Disease
Device: Transcranial direct current stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Apathy Symptoms [ Time Frame: Differences in outcome measure comparing second week to baseline ] [ Designated as safety issue: No ]
    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).


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham tDCS
sham-tDCS application every 2 days for 2 weeks (total of 6 applications)
Device: Transcranial direct current stimulation
tDCS 2 mA, dorsolateral pre-frontal cortex
Experimental: Transcranial direct current stimulation
tDCS application every 2 days for 2 weeks (total of 6 applications)
Device: Transcranial direct current stimulation
tDCS 2 mA, dorsolateral pre-frontal cortex

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481558

Locations
Brazil
University of São Paulo Medical School
São Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Felipe Fregni, MD, PhD, MPH Harvard Medical School
Study Chair: Ricardo Nitrini, MD, PhD University of Sao Paulo
Principal Investigator: Claudia K Suemoto, MD, PhD University of Sao Paulo
Study Chair: Ester Nakamura-Palacios, MD, PhD Federal University of Espirito Santo
Study Chair: Daniel Apolinário, MD University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudia Kimie Suemoto, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01481558     History of Changes
Other Study ID Numbers: 0679/11
Study First Received: November 21, 2011
Results First Received: March 20, 2013
Last Updated: December 9, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Apathy
Alzheimer's Disease
Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014