Enhancing Attention in Elderly Using a Brain-Computer-Interface

NCT07441122 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00008768
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive reserve refers to the brain's ability to maintain cognitive performance despite age-related changes or neuropathology. Enhancing cognitive reserve is thought to delay cognitive decline and improve functional outcomes in aging and neurodegenerative conditions. Attention and memory-related neural processes are considered key contributors to cognitive reserve, yet it remains unclear whether these neural markers can be deliberately strengthened through targeted training and non-invasive interventions. The goal of this clinical study is to investigate whether mindfulness-based meditation and non-invasive brain stimulation can enhance neural markers of attention and memory that serve as proxies for cognitive reserve in cognitively healthy adults and older adults diagnosed with mild cognitive impairment (MCI). Investigators hypothesize that strengthening these neural markers will lead to measurable improvements in cognitive reserve-related functions in both healthy aging and MCI populations. This study further hypothesizes that neural markers of attention can be selectively enhanced using an electroencephalography (EEG)-based brain-computer interface (BCI) combined with non-invasive interventions such as mindfulness-based relaxation or neuromodulation. During the study, participants will perform a computerized memory task while their EEG signals are recorded in real time. A BCI will analyze these signals to decode the presence or absence of the P300 event-related potential, a well-established neural marker of attentional control and cognitive resource allocation. Real-time feedback and intervention will be used to modulate these neural processes with the goal of promoting adaptive changes in attention-related brain activity. By integrating EEG-based decoding, behavioral training, and non-invasive interventions, this study aims to determine whether targeted modulation of attention-related neural activity can support cognitive reserve in aging and mild cognitive impairment.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

MCI; Memory; Cognitive Decline; Older Adults; Memory Impairment; Cognitive Control; Attention

Outcome Measures

Primary Outcomes (1)

• Change in neural correlates of attention across different intervention sessions

  This outcome measures whether neural correlates of attentional markers (e.g. amplitude, peak-to-peak, band power and connectivity measures of neural correlates) change across sessions as a result of intervention.

  From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)

Secondary Outcomes (1)

• Change in correct answer rate of memory task across intervention sessions

  From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)

Study Arms (4)

Behavior-based Attention control with Meditation

ACTIVE COMPARATOR

Subjects complete an nback task after a meditation intervention in which ground truth visual feedback is provided at the end of each run.

Behavioral: Mindfulness Meditation

Behavior-based Attention control with Open-Loop tACS

ACTIVE COMPARATOR

Subjects complete an nback task after a tACS intervention in which ground truth visual feedback is provided at the end of each run.

Device: transcranial electrical stimulation

EEG-based Attention Control and Meditation

EXPERIMENTAL

Subjects complete an nback task in which EEG-based visual feedback is provided after each trial

Behavioral: Mindfulness Meditation

EEG-Based Attention Control and Open-Loop tACS

EXPERIMENTAL

Subjects complete an nback task in which EEG-based visual feedback is provided after each trial

Device: transcranial electrical stimulation

Interventions

transcranial electrical stimulation DEVICE

tACS is delivered as a pre-task neuromodulatory intervention intended to prime neural activity before cognitive assessment. Electroencephalography (EEG) signals will be recorded from subjects as they perform nback tasks. The neural correlates of attention will be processed and decoded in real-time using machine learning algorithms to provide feedback. Subjects are instructed to assume a mental state/find a strategy to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of nback training with this intervention.

Also known as: tACS

Behavior-based Attention control with Open-Loop tACS; EEG-Based Attention Control and Open-Loop tACS

Mindfulness Meditation BEHAVIORAL

A relaxation protocol based on mindfulness meditation will be carried out. This consists of closing the eyes and focusing on breathing and relaxing for a period of 5 minutes. Electroencephalography (EEG) signals will be recorded from subjects as they perform nback tasks. The neural correlates of attention will be processed and decoded in real-time using machine learning algorithms to provide feedback. Subjects are instructed to assume a mental state/find a strategy to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of nback training with this intervention

Also known as: Relaxation, Meditation

Behavior-based Attention control with Meditation; EEG-based Attention Control and Meditation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Younger adults:
• Good general health.
• Normal or corrected vision.
• no history of neurological/psychiatric disease
• ability to read and understand English
• ability to understand information and ability to give a free and informed consent
• Older adults:
• Normal or corrected vision.
• Self-reports no current diagnosis of dementia.
• Ability to provide written/electronic, informed consent.

You may not qualify if:

• Younger Adults:
• Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy/seizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
• Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
• Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).
• Older Adults:
• Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy/seizure brain damage, pacemakers, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
• Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
• Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).
• Diagnosis of dementia.
• Do not have the capacity to provide informed consent.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Engineering Education and Research Center

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Interventions

Transcranial Direct Current Stimulation; Mindfulness; Meditation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)