Mild Cognitive Impairment (MCI)NCT06628427
Unlock the Secrets of Ageing Brains Through P300 Brain-computer Interface Games
An observational study of Mild Cognitive Impairment (MCI), run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- MoCA Test, Random Dot Motion (RDM) task and P300-BCI task without feedback
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2024to 14 Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Sheffield
Sheffield, South Yorkshire, S3 7ES
Mahnaz Arvaneh, +44 1142225649, m.arvaneh@sheffield.ac.uk
Jin Ni, +44 7787100398, jni14@sheffield.ac.uk
About this study
Official title: Effects of Different Parameter Settings on the Classification Accuracy of P300-BCI Speller in Elderly Adults with and Without Mild Cognitive Impairments
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- MoCA Test, Random Dot Motion (RDM) task, P300-BCI task without feedback
- Keywords
- Brain-computer Interface, Mild Cognitive Impairment, EEG, P300, Elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCA TestDiagnostic 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.
Random Dot Motion (RDM) taskDevice
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.
P300-BCI task without feedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Elderly with Mild Cognitive Impairments | Not described Receives: Diagnostic Test: MoCA Test; Device: Random Dot Motion (RDM) task; Device: P300-BCI task without feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 9 months.
Secondary outcomes (6)
The scores of the Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) was validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI) in hundreds of peer-reviewed studies since 2000. It has been widely adopted in clinical settings and used in academic and non-academic research around the world. The results of MoCA are interpreted based on a score range, with higher scores indicating less cognitive impairment:
26-30: Normal cognition 18-25: Mild cognitive impairment 10-17: Moderate cognitive impairment Under 10: Severe cognitive impairment
Measured: Through study completion, an average of 9 months.
Reaction times of the Random Dot Motion (RDM) test
In the Random Dot Motion (RDM) test, the reaction times of the mild cognitive impairment (MCI) patients are slower and more variable.
Measured: Through study completion, an average of 9 months.
Error rates of the Random Dot Motion (RDM) test
In the Random Dot Motion (RDM) test, the error rates of the mild cognitive impairment (MCI) patients are higher, particularly in challenging conditions (e.g., low coherence level).
Measured: Through study completion, an average of 9 months.
Characteristics of the P300 amplitude across different settings
P300 amplitude refers to the magnitude of the positive deflection in the EEG signal occurring approximately 300 milliseconds after the presentation of a target stimulus. The P300 amplitude is typically measured in microvolts (µV). Data will be averaged across trials for each participant.
Measured: Through study completion, an average of 9 months.
Characteristics of the P300 latency across different settings
P300 latency represents the time interval between the onset of a target stimulus and the peak of the P300 wave in the EEG signal, which is a measure of the speed of cognitive processing. The P300 latency will be measured in milliseconds (ms) and will be calculated by averaging across task trials for each participant.
Measured: Through study completion, an average of 9 months.
Answers to the two questionnaires, using a 10-point rating scale
Measured: Through study completion, an average of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion14 May 2025 (estimated)
- Study completion14 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahnaz Arvaneh, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628427
- Sponsor's protocol ID
- IRAS346367
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share anonymized data from the study, including raw EEG data and relevant metadata. The data will be available starting six months after publication and will remain accessible for a period of five years. Researchers who wish to access the data will be required to submit a formal request, and access will be granted upon approval by our data access committee.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Parameter Settings on the Classification Accuracy of P300-BCI Speller in Elderly Adults with and Without Mild Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06628427
- Acronym / sponsor ID
- IRAS346367
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Brain-computer Interface, Mild Cognitive Impairment, EEG, P300, Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 14 May 2025 (estimated)
- Study completion
- 14 Jul 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly with Mild Cognitive Impairments | – | Diagnostic Test: MoCA Test, Device: Random Dot Motion (RDM) task, Device: P300-BCI task without feedback |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoCA TestMoCA (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. | Diagnostic test | Elderly with Mild Cognitive Impairments |
| Random Dot Motion (RDM) taskRandom 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. | Device | Elderly with Mild Cognitive Impairments |
| P300-BCI task without feedbackTwo 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. | Device | Elderly with Mild Cognitive Impairments |
Primary outcome
Accuracy of the Brain-Computer Interface (BCI) model across different settings which is being tested
Time frame: Through study completion, an average of 9 months.
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.
6 secondary outcomes
The scores of the Montreal Cognitive Assessment (MoCA)
Time frame: Through study completion, an average of 9 months.
Reaction times of the Random Dot Motion (RDM) test
Time frame: Through study completion, an average of 9 months.
Error rates of the Random Dot Motion (RDM) test
Time frame: Through study completion, an average of 9 months.
Characteristics of the P300 amplitude across different settings
Time frame: Through study completion, an average of 9 months.
Characteristics of the P300 latency across different settings
Time frame: Through study completion, an average of 9 months.
Answers to the two questionnaires, using a 10-point rating scale
Time frame: Through study completion, an average of 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes. We plan to share anonymized data from the study, including raw EEG data and relevant metadata. The data will be available starting six months after publication and will remain accessible for a period of five years. Researchers who wish to access the data will be required to submit a formal request, and access will be granted upon approval by our data access committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahnaz Arvaneh principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI), run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahnaz Arvaneh (+44 1142225649, m.arvaneh@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Brain-Computer Interface (BCI) model across different settings which is being tested (time frame: Through study completion, an average of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.