Personalized Closed-Loop Brain Stimulation for Patients With Mild Cognitive Impairment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07512193
Status
Not Yet Recruiting

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Conditions

  • MCI

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Active tES — DEVICE
    This three-week, closed-loop program integrates personalized tES with computerized cognitive training to drive neuroplasticity. Following baseline electroencephalogram (EEG) mapping, participants undergo daily 30-minute sessions consisting of four "loops." Each loop begins with an AI-analyzed EEG to calibrate stimulation parameters, followed by 5-minute stimulation periods.
  • Cognitive Interventions — BEHAVIORAL
    In between tES treatment loops, the participants will be asked to complete cognitive exercises. By pairing real-time brain modulation with targeted executive function exercises, the intervention aims to improve language skills and clinical outcomes through precise, data-driven cortical targeting.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized closed-loop tES treatment + Cognitive Interventions
    Participants will receive personalized, closed-loop active tES for 3 weeks. Active tES will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tES and will take approximately 30 minutes to complete.

Primary Outcome Measure

Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically related - trained word-lists [ Time Frame: Before intervention, immediately after intervention and 1 month post intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Kyrana Tsapkini, PhD
[email protected]
410-736-2940

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By research site
Johns Hopkins Hospital· Baltimore, MD

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