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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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Participants will be asked to participate in this research study of a device that creates transcranial direct current stimulation (tDCS).
The researchers hope to learn if 30 minute sessions of transcranial direct current stimulation (tDCS) improve such a mood or feelings in people with Alzheimer's Disease.
This study involves the use of an investigational device called a tDC stimulator. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for treating Alzheimer's Disease.
This study will help find out what effects, good and/or bad, this has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known.
Three in-person visits will occur: (1) on the week prior to the first day of stimulation visit patients will undergo brain MRI scan to collect T1, T2, DWI and resting state functional MRI (rs-fMRI), and functional Near-Infrared Spectroscopy/Electroencephalography (fNIRS/EEG) imaging. In this visit, patients and caregivers will be taught how to operate the tDCS device and will receive a unit to take home; (2) on the day after completing the first treatment period, patients will undergo a second MRI scan with the same sequences and fNIRS/EEG imaging; (3) on the day after completing the second treatment period, at the end of week 5, patients will return the tDCS device to the study team and perform a last fNIRS/EEG imaging.
At in-person visits and during treatment periods patients will be asked questions regarding tolerability and acceptability, including monitoring for side effects, as well as completing questionnaires that assess cognition and NPS. All sessions will be remotely supervised via video conference platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TDCS treatment | Experimental | The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. |
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| Sham TDCS treatment | Sham Comparator | Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Device | The active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score | A 12 item questionnaire that measures a broad range of psychiatric symptoms. Each individual item is scored from 0 to 3. Total scores range from 0 to 36, with higher scores indicating more severe symptoms. | Baseline to Day 35 |
| Brief Dimensional Apathy Scale (bDAS) | A 9 item scale completed by caregivers about the participant. Each item is scored from 0 to 3. Total scores range from 0-27 with a higher score indicating more severe apathy. | Baseline to Day 35 |
| Caregiver version of the Irritability Questionnaire (IrQ) How often | A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more frequent symptoms. | Baseline to Day 35 |
| Caregiver version of the Irritability Questionnaire (IrQ) How much | A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more severe symptoms. | Baseline to Day 35 |
| Cornell Scale for Depression in Dementia (CSDD) | A 19 item scale which is scored as follows: a - Unable to evaluate the sign or symptom 0 - Absent
| Baseline to Day 35 |
| Generalized Anxiety Disorder-7 Scale (GAD-7) | A 7 item scale scored as follows: 0 - Not at all
|
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Inclusion Criteria:
Caregiver
Exclusion Criteria:
Caregiver
1. Any individual who does not meet all the inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thiago Macedo e Cordeiro, MD, MSc | Contact | 210-450-7055 | macedoecorde@uthscsa.edu | |
| Antonio L Teixeira, MD, PhD | Contact | 210-450-8636 | teixeiraa@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thiago Macedo e Cordeiro, MD, MSc | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
Data collected for this study will be analyzed and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio, for use by other researchers including those outside of the study. Permission to transmit data to the Glenn Biggs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio will be included in the informed consent.
When the study is completed and data is analyzed.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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This is a randomized double-blind cross-over clinical trial to investigate the effects of transcranial direct current stimulation (tDCS) over affective symptoms (AS) of patients with Alzheimer's disease (AD). The study will also investigate underlying neurobiological mechanisms of tDCS in AD with functional and structural neuroimaging techniques.
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Patients will be blinded throughout the trial. As the application of tDCS electrical current over the skin can be perceived by the participants, the study team will employ a sham condition that has been shown to be reliable and indistinguishable from active treatment in previous clinical trials published in the available scientific literature. An individual on the study team will be delegated to randomize and program and re-program devices. Participants will act as their own control. The researcher supervising the stimulation will be blinded to the intervention the participant is receiving.
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|
| Sham tDCS | Device | Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. |
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| Baseline to Day 35 |
| Montreal Cognitive Assessment (MoCA) | A battery of cognitive assessment tasks. Total possible score that can be achieved is between 0-30. A higher score indicating better cognition. | Baseline to Day 35 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |