Non-invasive BCI for Cognitive Enhancement

NCT05311878 | Completed FDA Device

• 1 other identifier: 2020030073_p2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

People's perceptual skills can significantly affect their abilities to make optimal decisions, judgments, and actions in real-world dynamic environments. Perceptual learning refers to training and experiences to induce improvements in the ability to make sense of what people see, hear, feel, taste or smell based on ambiguous sensory information. In this study, investigators hypothesise that there exist neural signatures that robustly encode the conscious visual perception of rotations of a cursor and the magnitudes of these rotations in a novel, rotation-based perceptual learning task. Investigators also hypothesise that online, instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively than behaviour perceptual training, especially in very small rotation magnitudes that represent extremely difficult perceptual tasks.

Conditions

Healthy Subjects; Neuropsychiatric Disorders

Outcome Measures

Primary Outcomes (1)

• Change in correct answer rate of different rotation magnitudes across 5 intervention sessions

  The correct answer rate per rotation magnitude reflects the improvements in perceptual skills across the two conditions. It measures the percentage of each rotation magnitude spotted correctly. The score is 0-100, and the higher the value, the better the outcome.

  Difference is measured every 24 hours, before versus after each intervention session

Secondary Outcomes (1)

• Change in neural correlates of conscious perception across 5 intervention sessions

  Difference is measured every 24 hours, before versus after each intervention session

Study Arms (2)

EEG based perceptual training

EXPERIMENTAL

Subjects complete a perceptual learning task in which EEG-based visual feedback is provided

Device: EEG-based perceptual training

Behavior based perceptual training

ACTIVE COMPARATOR

Subjects complete a perceptual learning task in which ground truth visual feedback is provided

Device: Behavior based perceptual training

Interventions

EEG-based perceptual training DEVICE

Electroencephalography (EEG) signals will be recorded from subjects as they perform rotation-based perceptual tasks. The neural correlates of conscious perception of rotations 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 perceptual training with this intervention.

EEG based perceptual training

Behavior based perceptual training DEVICE

Subjects complete the rotation-based perceptual tasks, and ground truth visual feedback is provided indicating whether subjects have spotted the rotations correctly. Subjects are instructed to spot as many rotation as possible to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of perceptual training with this intervention.

Behavior based perceptual training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able-bodied volunteers:
• 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
• Subjects with neuropsychiatric diseases
• Subjects with neuropsychiatric diseases such as bipolar disorder and schizophrenia.
• normal or corrected vision
• ability to read and understand English
• ability to understand information and ability to give a free and informed consent

You may not qualify if:

• short attentional spans or cognitive deficits that prevent to remain concentrated during the experimental sessions
• concomitant serious illnesses (e.g., metabolic disorders, cardiac arrest)
• factors hindering proper EEG acquisition (e.g., scalp wound, uncontrolled muscle activity)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Engineering Education and Research Center

Austin, Texas, 78712, United States

Location

Study Officials

• Jose del R. Millan, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 5, 2022
• Study Start: January 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)