Study design and purpose: This project will provide evidence as to whether a symptom-specific brain circuit-based neuromodulation intervention combining tDCSPFC and tACSAG can improve the functional impact of a tES intervention for older adults with 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 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
Alzheimer's disease, Depression
All genders
55+
Recruiting now
Overview
Principal Investigator: Davide Balos Cappon, MS, PhD
Contact Us
Eilis Reardon
Study details
Inclusion Criteria
- 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, as well as an informant who is willing and able to fill out questionnaires
about the participant's functional state
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
Exclusion Criteria
- 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
Study Requirements
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 IRBapproved informed consent form. A medical history questionnaire will be completed and medications, blood pressure, height, body mass and years of education will be recorded. Trained study personnel will characterize cognitive status of potential participants using measures the CDR and 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 the Beth Israel Deaconess Medical Center, located near
the Clinical Research Lab.
Visit 3—Baseline assessments (3 hrs): This assessment will take place remotely via telemedicine
and comprise assessment of depression symptoms and mood, cognition, 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, and with
EEG data being collected in the lab during the procedure.
Visit 5 Follow-up: After completing the tES home-based intervention, participants will repeat the
baseline assessment at 3 months follow up