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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01481558
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Apathy; Alzheimer's Disease	Device: Transcranial direct current stimulation	Phase 2

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
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 (HMS and HSDM)
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Claudia Kimie Suemoto, Assistant Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01481558
• Other Study ID Numbers: 0679/11
• First Posted: Nov 29, 2011
• Last Update Posted: Jan 9, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Claudia Kimie Suemoto, Assistant Professor, University of Sao Paulo: Apathy; Alzheimer's Disease; Dementia
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Recruitment Details	Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic

Arm/Group Title	Sham Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation
Arm/Group Description	One application of sham tDCS every two days (total: 6 applications)	One application of tDCS every two days (total: 6 applications)
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sham Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation	Total
Arm/Group Description	One application of sham tDCS every two days (total: 6 applications)	One application of tDCS every two days (total: 6 applications)	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 5%	1 5%	2 5%
>=65 years	19 95%	19 95%	38 95%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.6 (8.0)	79.4 (7.1)	80.5 (7.5)
Sex: Female, Male (Count of Participants)
Female	13 65%	15 75%	28 70%
Male	7 35%	5 25%	12 30%
Region of Enrollment (participants) [Number]
Brazil	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5. Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data.

Arm/Group Title	Sham Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation
Arm/Group Description	One application of sham tDCS every two days (total: 6 applications)	One application of tDCS every two days (total: 6 applications)
Measure Participants	20	20
Mean (95% Confidence Interval) [units on a scale]	-2.05	-1.95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Transcranial Direct Current Stimulation, Transcranial Direct Current Stimulation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.01
	Estimation Comments

Adverse Events

Arm/Group Title	Sham Transcranial Direct Current Stimulation		Transcranial Direct Current Stimulation
Arm/Group Description	One application of sham tDCS every two days (total: 6 applications)		One application of tDCS every two days (total: 6 applications)
All Cause Mortality
	Sham Transcranial Direct Current Stimulation		Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sham Transcranial Direct Current Stimulation		Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Sham Transcranial Direct Current Stimulation		Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.