Brain Stimulation for Mild Cognitive Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Neurological disease, Hearing loss, Visual acuity loss, Advanced dementia, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain stimulation technique for individuals with mild cognitive impairment (MCI), often a precursor to Alzheimer's Disease. The study employs a personalized closed-loop brain stimulation approach, combined with cognitive exercises, to determine its effect on learning and memory. Participants receive tailored electrical stimulation to specific brain areas, guided by real-time data and AI insights. Individuals diagnosed with probable Alzheimer's Disease and possessing a high school education might be suitable candidates for this study. The goal is to evaluate whether this method can become a cost-effective, home-based therapy option in the future. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to innovative home-based therapies.

What prior data suggests that this brain stimulation technique is safe for individuals with mild cognitive impairment?

Research has shown that personalized brain stimulation is generally safe and well-tolerated. For example, studies have found that transcranial electrical stimulation (tES) is well-tolerated by individuals with memory or thinking problems. Participants in these studies rarely report serious side effects. Most side effects, if they occur, are mild and temporary, such as slight tingling or itching on the scalp where the electrodes are placed.

The technology used in this trial is non-invasive, meaning it doesn't involve surgery or entering the body, which usually lowers the risk. Since this type of brain stimulation has been used safely for other conditions, it is expected to be similarly safe for individuals with mild memory or thinking issues. Always consult the trial team to fully understand any possible risks or side effects for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized closed-loop brain stimulation for mild cognitive impairment because it offers a novel approach by tailoring the treatment to each individual's brain activity in real time. Unlike current medications that broadly target symptoms, this method uses a closed-loop system to provide transcranial electrical stimulation (tES) precisely when needed, potentially enhancing cognitive functions more effectively. Moreover, combining this stimulation with concurrent cognitive training exercises could synergistically boost brain performance, offering a more dynamic and personalized intervention than traditional therapies.

What evidence suggests that this personalized closed-loop brain stimulation is effective for mild cognitive impairment?

Research has shown that personalized brain stimulation could enhance thinking skills in people with mild cognitive impairment (MCI). This non-invasive technique targets specific brain areas without requiring surgery. In this trial, participants will receive personalized, closed-loop brain stimulation combined with cognitive interventions. The approach uses real-time data and artificial intelligence to adjust the stimulation, potentially aiding memory and learning. Early results suggest this method might surpass general brain stimulation techniques in effectiveness. Studies supporting these findings have noted improved mental control and outcomes in similar groups. ^{1 2 4 6 7}

Who Is on the Research Team?

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with probable Alzheimer's disease using tests and biomarkers.

* 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).

I am between 45 and 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized, closed-loop active tES for 3 weeks, with concurrent cognitive training exercises

3 weeks

20-minute tES sessions with 30-minute cognitive training exercises

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

Monitoring at 1 month post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Closed-Loop Brain Stimulation

How Is the Trial Designed?

Group I: Personalized closed-loop tES treatment + Cognitive Interventions Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Mackler-Goding Foundation

Collaborator

Citations

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clinicaltrials.gov/study/NCT05907343

Closed-Loop Brain Stimulation as a Potential Intervention ...

The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively ...

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trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/591579

Closed-Loop Brain Stimulation as a Potential Intervention ...

The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in ...

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trial.medpath.com

trial.medpath.com/clinical-trial/2db287d9f3658fad/nct07512193-personalized-closed-loop-brain-stimulation-mild-cognitive-impairment

Personalized Closed-Loop Brain Stimulation for Patients With ...

This research study investigates the feasibility and efficacy of a personalized, closed-loop electroencephalogram-transcranial electrical stimulation ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11796046/

Efficacy of non-invasive brain stimulation interventions ... - PMC

To synthesize evidence from SRMAs assessing the effectiveness of NIBS techniques on cognitive and mental outcomes in AD and MCI populations.

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biorxiv.org

biorxiv.org/content/10.1101/2021.03.18.436018.full

Personalized Closed-Loop Brain Stimulation for Effective ...

pBO successfully searches, learns, and recommends parameters for an effective neurointervention as supported by behavioral, stimulation, and neural data.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0166432826000549

Combined transcranial electrical stimulation (tES) and ...

The aim of this review is to comprehensively explore the impacts of the combined tES and CT interventions on cognitive disorders and healthy ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12788793/

Personalized cognitive enhancement for older adults - PMC

Emerging digitally delivered non-pharmacological interventions (dNPIs) offer scalable, low-risk solutions for enhancing cognitive function ...