Personalized Closed-Loop Brain Stimulation for Patients With Mild Cognitive Impairment
Trial ID: NCT07512193
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-06
Completion date: 2026-08
Sponsor: Johns Hopkins University
Collaborators: Mackler-Goding Foundation
Conditions: MCI
Interventions: Active tES; Cognitive Interventions
Locations: Johns Hopkins Hospital
Countries: United States
Enrollment: 10
Age range: 45 Years - 85 Years
Sex: ALL

Summary:
This research study investigates the feasibility and efficacy of a personalized, closed-loop electroencephalogram-transcranial electrical stimulation (EEG-tES) intervention for individuals with mild cognitive impairment (MCI), addressing the inconsistent results of generic brain stimulation protocols. By integrating artificial intelligence (AI)-derived insights with real-time data, the study aims to customize transcranial electrical stimulation (tES) parameters, including electrode placement, intensity, and frequency to target the specific brain regions responsible for abnormal signaling in each participant. Over the intervention period paired with computerized cognitive training, the project will evaluate improvements in learning, memory, and functional connectivity, while simultaneously identifying clinical and physiological predictors to determine the viability of transitioning this low-cost, non-invasive technology into a remotely supervised, home-based therapy setting. The study duration will be a total of 6-8 weeks.

Eligibility criteria:
Inclusion Criteria:

* Must be between 45-85 years of age.
* Must be proficient in English.
* Must have a minimum of high-school education.
* Must be diagnosed with 'probable Alzheimer's Disease (AD)' in specialized diagnostic centers with neuropsychological (e.g., RAVLT) and AD biomarkers according to 2011 guidelines.
* The investigators will also perform extensive testing in the investigators' test battery including the Mnemonic Similarity Test (MST) that discriminates and measures the most salient hippocampal deficit-pattern separation (PS).

Exclusion Criteria:

* People with previous neurological disease including vascular dementia (e.g., stroke, developmental dyslexia, dysgraphia or attentional deficit).
* People with hearing loss (\> 25 decibel, using audiometric hearing screen).
* People with uncorrected visual acuity loss.
* People with advanced dementia or severe language impairments (MMSE \<15, or Montreal Cognitive Assessment \<10, or language Frontotemporal Dementia-specific Clinical Dementia Rating (FTD-CDR) =3).
* People with pre-existing psychiatric disorders such as behavioral disturbances, severe depression, or schizophrenia that do not allow these people to comply or follow the study schedule and requirements such as repeated evaluation and therapy.

Outcomes:
Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists; Change in auditory delayed recall accuracy of semantically related - trained word-lists; Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - trained word-lists; Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists; Change in auditory recall accuracy based the sum of words recalled in Trials 1-5 of semantically related - untrained word-lists; Change in auditory delayed recall accuracy of semantically related - untrained word-lists; Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - untrained word-lists; Change in auditory delayed recall accuracy of semantically unrelated - untrained word-lists