Mild Cognitive Impairment (MCI)NCT07441122
Enhancing Attention in Elderly Using a Brain-Computer-Interface
A study testing transcranial electrical stimulation and Mindfulness Meditation in people with Mild Cognitive Impairment (MCI), run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- transcranial electrical stimulation and Mindfulness Meditation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Older adults:
- Normal or corrected vision.
- Self-reports no current diagnosis of dementia.
- Ability to provide written/electronic, informed consent.
Who cannot join
- 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.).
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Jose del R. Millan, PhD, 512-232-8111, jose.millan@austin.utexas.edu
Khushi Thorat, 512-495-5521, BrainFit@austin.utexas.edu
- Recruiting
Sun City
Georgetown, Texas, 78633
Khushi Thorat, 512-495-5521, BrainFit@austin.utexas.edu
About this study
Official title: Building Cognitive Reserve Through Brain-Computer-Interfaces
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.
Read more
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)
- Being tested
- transcranial electrical stimulation, Mindfulness Meditation
- Keywords
- MCI, Memory, Cognitive Decline, Older Adults, Memory Impairment, Cognitive Control, Attention
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulationDevice
Also called tACS
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 MeditationBehavioural
Also called Relaxation, 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: Device: transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The correct answer rate per nback run reflects the improvements in attentional and memory skills across the two conditions. It measures the percentage of each trial memorized correctly. The score is 0-50, and the higher the value, the better the outcome.
Measured: From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jul 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose del R. Millan, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441122
- Sponsor's protocol ID
- STUDY00008768
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data will be made available by the online publication date. These data will be placed in public servers for any interested researcher to access it.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Cognitive Reserve Through Brain-Computer-Interfaces
- ClinicalTrials.gov ID
- NCT07441122
- Acronym / sponsor ID
- STUDY00008768
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- MCI, Memory, Cognitive Decline, Older Adults, Memory Impairment, Cognitive Control, Attention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behavior-based Attention control with Meditation | Active comparator | Behavioral: Mindfulness MeditationSubjects complete an nback task after a meditation intervention in which ground truth visual feedback is provided at the end of each run. |
| Behavior-based Attention control with Open-Loop tACS | Active comparator | Device: transcranial electrical stimulationSubjects complete an nback task after a tACS intervention in which ground truth visual feedback is provided at the end of each run. |
| EEG-based Attention Control and Meditation | Experimental | Behavioral: Mindfulness MeditationSubjects complete an nback task in which EEG-based visual feedback is provided after each trial |
| EEG-Based Attention Control and Open-Loop tACS | Experimental | Device: transcranial electrical stimulationSubjects complete an nback task in which EEG-based visual feedback is provided after each trial |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial electrical stimulationAlso: tACStACS 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. | Device | Behavior-based Attention control with Open-Loop tACS, EEG-Based Attention Control and Open-Loop tACS |
| Mindfulness MeditationAlso: Relaxation, MeditationA 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 | Behavioural | Behavior-based Attention control with Meditation, EEG-based Attention Control and Meditation |
Primary outcome
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)
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.
1 secondary outcome
Change in correct answer rate of memory task across intervention sessions
Time frame: From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. All data will be made available by the online publication date. These data will be placed in public servers for any interested researcher to access it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical stimulation and Mindfulness Meditation in people with Mild Cognitive Impairment (MCI), run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose del R. Millan, PhD (512-232-8111, jose.millan@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.