NCT06801639

Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms

Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS)	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.
DEVICE	Sham tDCS	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.

Timeline

• Start date: 2025-07-15
• Primary completion: 2028-02-01
• Completion: 2028-12-01
• First posted: 2025-01-30
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study