Clinical trial NCT06628427: Unlock the Secrets of Ageing Brains Through P300 Brain-computer Interface Games
Official title: Effects of Different Parameter Settings on the Classification Accuracy of P300-BCI Speller in Elderly Adults with and Without Mild Cognitive Impairments
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Brain-computer Interface
Mild Cognitive Impairment
EEG
P300
Elderly
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: The Electroencephalogram (EEG) is widely used in clinical practice to assess various neurological disorders. It records the brains spontaneous electrical activity, providing a non-invasive way to visually examine brain signals. By analysing these signals, we aim to gain valuable insights into cognitive impairments and the cognitive processes of the ageing brain. The P300 is an event-related potential (ERP) that serves as a crucial EEG-based biomarker, whose amplitude and latency are key points of research in cognitive impairments. Typically elicited by a visual speller, the P300 could be used for the communication through brain-computer interface (BCI). A P300-based BCI enables communication by detecting the P300 response to specific target letters, allowing users to select letters they wish to spell through interactive interface. In this study, we will recruit 15 elderly participants with mild cognitive impairment (MCI) symptoms and 15 controls without MCI. We will customise the P300-BCI by adjusting the inter-stimulus interval (ISI) and the matrix size which is the probability of the target presenting. This will help us investigate how these parameter settings influence the P300 components and the accuracy of the P300-BCI in both groups. Additionally, this study could help explore the potential of the P300-BCI to mitigate MCI symptoms and provide evidence for its further development.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Accuracy of the Brain-Computer Interface (BCI) model across different settings which is being tested
timeFrame: Through study completion, an average of 9 months.
Secondary outcomes:
measure: The scores of the Montreal Cognitive Assessment (MoCA)
timeFrame: Through study completion, an average of 9 months.
measure: Reaction times of the Random Dot Motion (RDM) test
timeFrame: Through study completion, an average of 9 months.
measure: Error rates of the Random Dot Motion (RDM) test
timeFrame: Through study completion, an average of 9 months.
measure: Characteristics of the P300 amplitude across different settings
timeFrame: Through study completion, an average of 9 months.
measure: Characteristics of the P300 latency across different settings
timeFrame: Through study completion, an average of 9 months.
measure: Answers to the two questionnaires, using a 10-point rating scale
timeFrame: Through study completion, an average of 9 months.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: The University of Sheffield
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Mahnaz Arvaneh
role: PRINCIPAL_INVESTIGATOR
References: