Enhancing Attention in Elderly Using a Brain-Computer-Interface

Official title

Building Cognitive Reserve Through Brain-Computer-Interfaces

Overview

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.

Interventions

• Device 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 ses
• Behavioral 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 f

Primary outcome measures

• 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)]

Secondary outcome measures (1)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• The University of Texas at Austin — Austin
• Sun City — Georgetown

Identifiers

NCT: NCT07441122 · STUDY00008768

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗