- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05311878
Non-invasive BCI for Cognitive Enhancement
November 13, 2023 updated by: University of Texas at Austin
Non-invasive Brain Computer Interface for Cognitive Enhancement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Engineering Education and Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: EEG based perceptual training
Subjects complete a perceptual learning task in which EEG-based visual feedback is provided
|
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.
|
Active Comparator: Behavior based perceptual training
Subjects complete a perceptual learning task in which ground truth visual feedback is provided
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in correct answer rate of different rotation magnitudes across 5 intervention sessions
Time Frame: Difference is measured every 24 hours, before versus after each intervention session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in neural correlates of conscious perception across 5 intervention sessions
Time Frame: Difference is measured every 24 hours, before versus after each intervention session
|
This outcome measures whether neural correlates of conscious perception (e.g.
amplitude, peak-to-peak, band power and connectivity measures of neural correlates) change across sessions as a result of intervention.
|
Difference is measured every 24 hours, before versus after each intervention session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jose del R. Millan, PhD, The University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
February 22, 2022
First Submitted That Met QC Criteria
March 25, 2022
First Posted (Actual)
April 5, 2022
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2020030073_p2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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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