Recruiting

Mindfulness & BCI

Sponsor:

University of Texas at Austin

Code:

NCT07441122

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

transcranial electrical stimulation

Mindfulness Meditation

Study Details

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)

Study ID

NCT07441122

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Behavior-based Attention control with Meditation

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

active comparator: Behavior-based Attention control with Open-Loop tACS

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

experimental: EEG-based Attention Control and Meditation

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

experimental: EEG-Based Attention Control and Open-Loop tACS

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

Interventions

transcranial electrical stimulation

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.

Mindfulness Meditation

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

Primary outcome measure

  • Change in neural correlates of attention across different intervention sessions [ Time Frame: From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults) ]

Central Contacts and Locations

Central contacts

Jose del R. Millan, PhD

512-232-8111jose.millan@austin.utexas.edu

Khushi Thorat

512-495-5521BrainFit@austin.utexas.edu

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Jose del R. Millan, PhD

512-232-8111jose.millan@austin.utexas.edu

Khushi Thorat

512-495-5521BrainFit@austin.utexas.edu

Principal Investigator:

Jose del R. Millan, PhD

Sun City

Recruiting

Georgetown, Texas, United States, 78633

Contacts

Khushi Thorat

512-495-5521BrainFit@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-07-27.