Unlock the Secrets of Ageing Brains Through P300 Brain-computer Interface Games

NCT06628427 | Not Yet Recruiting

• 1 other identifier: IRAS346367
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the use of Electroencephalography (EEG) in understanding mild cognitive impairment (MCI). EEG is commonly used in everyday clinical practice for the assessment of a wide range of neurological disorders. It records the brains spontaneous electrical signals and offers a non-invasive means of visually evaluating brain signals. By analysing these signals, we aim to uncover invaluable insights into cognitive impairments and the ageing brains cognitive processes.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Brain-computer Interface; Mild Cognitive Impairment; EEG; P300; Elderly

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Brain-Computer Interface (BCI) model across different settings which is being tested

  This outcome measure will assess the accuracy of the P300-based Brain-Computer Interface (BCI) system across different settings being tested. Using state-of-the-art BCI classification models, the accuracy of P300-BCI system classification will be determined through offline analysis of EEG data collected during the experiment.

  Through study completion, an average of 9 months.

Secondary Outcomes (6)

• The scores of the Montreal Cognitive Assessment (MoCA)

  Through study completion, an average of 9 months.

• Reaction times of the Random Dot Motion (RDM) test

  Through study completion, an average of 9 months.

• Error rates of the Random Dot Motion (RDM) test

  Through study completion, an average of 9 months.

• Characteristics of the P300 amplitude across different settings

  Through study completion, an average of 9 months.

• Characteristics of the P300 latency across different settings

  Through study completion, an average of 9 months.

Study Arms (1)

Elderly with Mild Cognitive Impairments

Diagnostic Test: MoCA Test; Device: Random Dot Motion (RDM) task; Device: P300-BCI task without feedback

Interventions

MoCA Test DIAGNOSTIC_TEST

MoCA (Montreal Cognitive Assessment or The MoCA Test) was validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI) in hundreds of peer-reviewed studies since 2000. MoCA has been widely adopted in clinical settings and used in academic and non-academic research around the world. The sensitivity of MoCA for detecting MCI is 90%, compared to 18% for the MMSE. Prospective participants meeting the eligibility criteria, as determined by the Montreal Cognitive Assessment (MoCA) test, will be invited to the Brain- Computer Interface (BCI) laboratory at the Kroto Research Centre on the University of Sheffield north campus to participate in the study.

Elderly with Mild Cognitive Impairments

Random Dot Motion (RDM) task DEVICE

Random Dot Motion task (RDM) has been widely used in research on spatial attention, and decision-making ability, etc., and its results (accuracy and reaction time) can be used as indicators to detect spatial attention. During the assessment, participants were required to monitor a series of dots in constant random motion on the screen. The dots sometimes moved coherently together to the left or right, and participants were required to press the left mouse button when they perceived them moving to the left and the right mouse button when they observed them moving to the right. We are going to use the motion coherence level of 50%. The higher the coherence level, the greater the number of dots moving together, and the combination of the moving direction and coherence level of the dots appear randomly during the task.

Elderly with Mild Cognitive Impairments

P300-BCI task without feedback DEVICE

Two different speller matrix sizes: 3×3 and 5×5, two inter-stimulus intervals (ISIs): 117ms (i.e., commonly used ISI for healthy adults) and 175ms (i.e., 50% longer than the widely used ISI) and two spelling words (QUICK and JUMP) are designed in this experiment to explore the calibration accuracy of these eight parameter combinations in the young and old groups and obtain the best parameter combination. The matrix contains letters and digits, and the target letters will be displayed below the matrix letter by letter. When the speller runs, the rows and columns in the matrix will flash 15 times each randomly. Each flash will last for 55ms, and the subsequent ISI will last for different times according to different parameter designs. Participants only need to focus on the target letter and silently count the number it flashes, as flashing target letters can generate P300 if well attended.

Elderly with Mild Cognitive Impairments

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be from the Sheffield Memory Clinic run by Dr Blackburn. This sees approximately 400 new patients per year of whom 15-20% have MCI, it is a research active clinic, and we have a database of people interested in taking part in research. Suitable participants will be identified in the clinic by a member of their clinical staff or contacted from their database.

You may qualify if:

• Diagnosed with mild cognitive impairments (MCI) or mild dementia
• Normal or corrected-to-normal vision
• Can maintain sitting with or without support for around 60 minutes continuously
• Cognitive and language abilities to understand and participate in the study protocol and able to give consent and understand instructions

You may not qualify if:

• Severe cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent
• Pre-existing severe systemic disorders like active cancer, end-stage pulmonary or cardiovascular disease, psychiatric illness including severe alcohol or drug abuse
• Past history of epilepsy- with seizures in last 12 months
• History of photosensitive epilepsy.
• Allergy to latex

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

The University of Sheffield

Sheffield, South Yorkshire, S3 7ES, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mahnaz Arvaneh

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahnaz Arvaneh

CONTACT

+44 1142225649; m.arvaneh@sheffield.ac.uk

Jin Ni

CONTACT

+44 7787100398; jni14@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: October 15, 2024
• Primary Completion: May 14, 2025
• Study Completion: July 14, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)