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Not yet recruiting NCT07512193

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

No phase Interventional MCI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tES, Cognitive Interventions.
Who it may be relevant to
Registry conditions: MCI. Basic parameters: 45 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Active tES
    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.
  • Behavioral Cognitive Interventions
    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.

Primary outcome measures

  • 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]
  • Change in auditory delayed recall accuracy of semantically related - trained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - trained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory recall accuracy based the sum of words recalled in Trials 1-5 of semantically related - untrained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory delayed recall accuracy of semantically related - untrained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory recall accuracy based on the sum of words recalled in Trials 1-5 of semantically unrelated - untrained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in auditory delayed recall accuracy of semantically unrelated - untrained word-lists [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
Secondary outcome measures (12)
  • Change in Rey Auditory-Verbal Learning Test (RAVLT) score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in Mini Mental State Examination (MMSE) [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in Mnemonic Similarity Task (MST) score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in word repetition score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in non-word repetition score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in sentence repetition score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in oral naming Boston Naming Test score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in oral naming Philadelphia Naming Test score [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in written naming as assessed by Boston Naming Test [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in written naming as assessed by Philadelphia Naming Test [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in oral naming of action as assessed by Hopkins Assessment of Naming Actions (HANA) [Time frame: Before intervention, immediately after intervention and 1 month post intervention]
  • Change in syntactic comprehension as assessed by Subject-relative, Object-relative, Active, Passive (S.O.A.P.) Syntactic Battery [Time frame: Before intervention, immediately after intervention and 1 month post intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT07512193 · IRB00553664

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗