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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS | Sham Comparator | sham-tDCS application every 2 days for 2 weeks (total of 6 applications) |
|
| Transcranial direct current stimulation | Experimental | tDCS application every 2 days for 2 weeks (total of 6 applications) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | tDCS 2 mA, dorsolateral pre-frontal cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Differences in outcome measure comparing second week to baseline |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD, MPH | Harvard Medical School (HMS and HSDM) | Study Director |
| Ricardo Nitrini, MD, PhD | University of Sao Paulo | Study Chair |
| Claudia K Suemoto, MD, PhD | University of Sao Paulo | Principal Investigator |
| Ester Nakamura-Palacios, MD, PhD | Federal University of Espirito Santo | Study Chair |
| Daniel Apolinário, MD | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo Medical School | São Paulo | São Paulo | 01246903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24262299 | Derived | 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. |
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Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Transcranial Direct Current Stimulation | One application of sham tDCS every two days (total: 6 applications) |
| FG001 | Transcranial Direct Current Stimulation | One application of tDCS every two days (total: 6 applications) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Transcranial Direct Current Stimulation | One application of sham tDCS every two days (total: 6 applications) |
| BG001 | Transcranial Direct Current Stimulation | One application of tDCS every two days (total: 6 applications) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Differences in outcome measure comparing second week to baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Transcranial Direct Current Stimulation | One application of sham tDCS every two days (total: 6 applications) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Kimie Suemoto | University of Sao Paulo | 551130618249 | cksuemoto@usp.br |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Transcranial Direct Current Stimulation | One application of tDCS every two days (total: 6 applications) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Transcranial Direct Current Stimulation | One application of tDCS every two days (total: 6 applications) | 0 | 20 | 0 | 20 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |