- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441122
Enhancing Attention in Elderly Using a Brain-Computer-Interface
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Austin, Texas, United States, 78712
- Engineering Education and Research Center
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Principal Investigator:
- José del.R Millan, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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
Other Names:
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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.
|
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.
Other Names:
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Experimental: EEG-based Attention Control and Meditation
Subjects complete an nback task in which EEG-based visual feedback is provided after each trial
|
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
Other Names:
|
|
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
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cognitive Dysfunction
- Memory Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Relaxation Therapy
- Transcranial Direct Current Stimulation
- Mindfulness
- Meditation
Other Study ID Numbers
- STUDY00008768
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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