Study design and purpose: This project will provide evidence as to whether a symptom-specific brain circuit-based neuromodulation intervention combining transcranial direct current stimulation targeting the left prefrontal cortex (tDCSPFC) and transcranial alternating current stimulation intervention targeting the left angular gyrus (tACSAG) can improve the functional impact of a transcranial electrical stimulation (tES) intervention for older adults with depressive symptoms in the context of Alzheimer’s dementia (DEP+AD). It will also reveal the specificity of the mapping between brain networks and symptoms, confirm the adequacy of the proposed approach for inducing sufficient electric field (En) in the targets, as well as provide the groundwork for tailored noninvasive stimulation intervention optimization in future studies.
Tele-supervised brain circuit-based transcranial electrical stimulation for memory and depressive symptoms in older adults living with dementia
Tele-supervised brain circuit-based transcranial electrical stimulation for memory and depressive symptoms in older adults living with dementia
55+
Overview
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Study details
- Our target population will be men and women age ≥ 55 years who have been well-characterized in terms of their AD biomarker profile status and undergone neuropsychological evaluations to evaluate cognitive decline. All potential participants must find a study partner who is willing, able, and available to conduct the tES intervention.
For eligible participants the following inclusion criteria apply:
At least moderate severity of depressive symptom severity defined by the Center for Epidemiological Studies- Depression (CES-D) score ≥ 16 - Mild dementia defined by a Mini Mental State Examination ≥20 and a Clinical Dementia Rating (CDR) score of ≤1
- Biomarker confirmation of AD by blood biomarker, CSF or amyloid PET
- Age<55
- Individuals with a history of bipolar affective disorder diagnosis or a primary psychotic disorder
- Dementia due to other causes, any history of other progressive or genetic neurologic disorder (e.g., Parkinson’s disease, multiple sclerosis, amyotrophic lateral sclerosis, multiple system degeneration, tubular sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain
injury, tumor), including intracranial lesions
Visit 1—In person screen and study familiarization: Individuals deemed potentially eligible via phone screen will complete an in-person visit. Individuals will read and sign an IRB approved informed consent form. A medical history questionnaire will be completed and medications will be recorded. Trained study personnel will characterize cognitive status of potential participants using the Clinical Dementia Rating (CDR) and Mini-Mental State Examination (MMSE).
Visit 2—Structural MRI: MRIs will enable tES current flow modeling. If participants do not have a recent structural MR image, T1, T2, and T2-weighted fluid-attenuated inversion recovery (T2 FLAIR) scans can be completed at Tufts Medical Center.
Visit 3—Baseline assessments (3 hrs): Comprises of assessments of depressive symptoms and mood, cognition, and instrumental activities of daily living and quality of life.
Visit 4 Immediate Follow-up: After completing the tES home-based intervention, participants will repeat the baseline assessment immediately post-intervention.
Visit 4.b – Electroencephalographic (EEG) assessment: Participants who agree, will undergo an EEG using a high density 257-channel EEG system. The EEG will be taken at resting state (i.e., seated, at rest), consisting of 5 minutes with eyes open and 5 minutes with eyes closed.
Visit 5 Follow-up: After completing the tES home-based intervention, participants will repeat the baseline assessment at 3 months follow up.