Mild Cognitive ImpairmentNCT06762522
Exploring Feasibility, Acceptability and Impact of Using Neurofeedback with Persons with Mild Cognitive Impairment
A study testing Nonlinear dynamical neurofeedback (NLD), Low energy neurofeedback system (LENS) and Brain Music in people with Mild Cognitive Impairment, run by Queen's University at 1 site in Canada.
Trial summary
The goal of this pilot study is to determine the feasibility, acceptability and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Nonlinear dynamical neurofeedback (NLD), Low energy neurofeedback system (LENS) and Brain Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with mild cognitive impairment (MCI) attending the Memory Clinic at Providence Care Hospital in Kingston, Ontario
Who cannot join
- Adults with cognitive issues related to a psychiatric diagnosis or acute brain injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Providence Care Hospital
Kingston, Ontario, K7L 4X3
Sarah Moore-Vasram, 613-544-4900 ext. 53540, moorevas@providencecare.ca
Sarah Walker, 613-484-3249, walker.s@queensu.ca
About this study
Official title: Exploring Feasibility and Acceptability of Using Neurofeedback Interventions to Manage Cognitive, Affective and Behavioural Symptoms in Persons with Mild Cognitive Impairment
The goal of this pilot study is to determine the feasibility, acceptability and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI). The main question[s] it aims to answer are: (1) What is the feasibility, acceptability, and appropriateness of using the Nonlinear Dynamical Neurofeedback intervention for persons living with MCI? (2) What is the feasibility, acceptability, and appropriateness of using the Low Energy Neurofeedback System (LENS) intervention for persons living with MCI? (3) What is the feasibility, acceptability, and appropriateness of using the Brain Music neurofeedback intervention for persons living with MCI? (4) What is the potential impact of five weeks of a neurofeedback intervention on cognitive, affective, and behavioural symptoms experienced by persons living with MCI? Participants will be randomly assigned to either the Nonlinear Dynamical (NLD), Low Energy Neurofeedback System (LENS), or Brain Music neurofeedback intervention groups or a control group receiving usual care.
Read the detailed description
Mild cognitive impairment (MCI) involves more severe memory, language, thinking, or judgment problems than normal aging, often progressing to dementia. Current treatments, both pharmacological and non-pharmacological, show limited benefits, prompting the need for alternative approaches like neurofeedback. Neurofeedback is a non-invasive technique that enhances the central nervous system's flexibility and resilience, potentially boosting cognitive reserve and delaying cognitive decline. This study focuses on three advanced neurofeedback methods: Nonlinear Dynamical Neurofeedback (NLD), Low Energy Neurofeedback System (LENS), and Brain Music. Before conducting a full clinical trial, it's crucial to determine if these methods are feasible and acceptable for people with MCI. This pilot study aims to explore the feasibility, acceptability, and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI).
The study involves a quasi-experimental design with 20 participants recruited from the Providence Care Hospital Memory Clinic in Kingston, Ontario. Participants will be randomly assigned to either the NLD, LENS, or Brain Music intervention groups or a control group receiving usual care. Each intervention will last five weeks, with assessments conducted before and after the intervention period. Clinical outcomes measured include objective cognitive assessments using the Creyos Health Cognitive Assessment. Subjective self-reported measures will include the Short-Form Pittsburgh Sleep Quality Index (SF-PSQI) survey to measure sleep quality, the Beck Depression Inventory (BDI) to measure depressive symptoms, and the Beck Anxiety Inventory (BAI) to measure anxiety. Feasibility and acceptability will be evaluated based on participation rates, survey responses, and withdrawal rates, along with the resources needed for the study. Data analysis will involve repeated measures ANOVAs to identify trends and assess the reliability of the measures used, providing foundational data for future research on neurofeedback's efficacy in managing MCI symptoms This data will inform the design of a larger clinical trial.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Nonlinear dynamical neurofeedback (NLD), Low energy neurofeedback system (LENS), Brain Music, Usual Care
- Keywords
- Neurofeedback, Feasibility
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonlinear dynamical neurofeedback (NLD)Other
Also called NeurOptimal neurofeedback, Brain training
NeurOptimal nonlinear dynamical (NLD) neurofeedback brain training works as a detection and monitoring system of changes in cortical patterns within the brain, mirroring the brain activity that can be undermining optimal brain function, providing the brain with the information it needs to make its own adjustments which over time results in the brain functioning more efficiently and effectively. Two scalp sensors at C3 \& C4 and two earclips at tops of ears (reference) and one on the earlobe (ground) are used to read EEG activity which is analyzed by the NeurOptimal software. As participants listen to music through earbuds, information is fed back to the individual by slight interruptions in the music. One session lasts 33.5 minutes.
Low energy neurofeedback system (LENS)Other
Also called Direct neurofeedback
Low energy neurofeedback system (LENS) therapy is an EEG-based direct neurofeedback system that stimulates the brain to reset itself and achieve optimal performance. Therapy consists of delivery of a tiny electromagnetic field carrying the feedback signal down the electrode wires for only one second at each of the chosen electrode sites during every session. Generally, between one and seven of the ordinary electrode sites are utilized during each session. Therapy is adapted to the participant's reactivity/sensitivity and the response of their nervous system.
Brain MusicOther
Also called Chen Medimo Corp. (CMC), CMC Brain Music
Chen Medimo Corp (CMC) Brain Music neurofeedback analyzes an individual's EEG brainwave patterns and translates them into orchestral music. Listening to this personalized brain music allows the individual to gain self-awareness and rewire and alter their own mental states. The Brain Music protocol requires regular in-person follow-ups for optimal results. Generally, the number of sessions varies based on individual needs and the progress made in response to the CMC Brain Music. A minimum of once a week in-person sessions is recommended for qEEG model updating to accurately track progress. Each session may last 30 minutes. Additionally, participants are advised to listen to their personalised music at least once a day, with a minimum of two listens per session. In general, participants may start to detect a change in their neurodevelopmental or cognitive function in 4-6 weeks.
Usual CareOther
Also called Control group
The Usual Care control group will be followed in the Memory clinic at intervals determined by their clinician. Usual Care for individuals with mild cognitive impairment (MCI) at the The Memory Clinic consists of inter-professional assessment, diagnosis and recommendations. There are currently no drugs approved to treat MCI. Therapy is aimed at managing treatable causes and contributors including medication side effects, thyroid problems, sleep apnea, vitabim B deficiency, depression, anxiety, and unrecognized or untreated difficulties with hearing or vision. Neurofeedback is not a component of the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Nonlinear dynamical neurofeedback (NLD) | Experimental | The NLD study intervention will consist of 10 sessions of NeurOptimal neurofeedback delivered twice a week over a 5-week period. The intervention will be delivered by a certified NeurOptimal trainer. The average session length is 45 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. Receives: Other: Nonlinear dynamical neurofeedback (NLD) |
| Low energy neurofeedback system (LENS) | Experimental | The LENS study intervention will consist of 5 sessions of LENS neurofeedback delivered by a certified LENS trainer once a week over a 5-week period. The average session length is 15 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. Receives: Other: Low energy neurofeedback system (LENS) |
| Brain Music | Experimental | The Brain Music study intervention will consist of a brain mapping data acquisition session to create the personalized music, followed by 5 weekly sessions to adjust the music that participants will listen to at home on a daily basis. Initial data acquisition and weekly sessions will take about 30 minutes. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. Receives: Other: Brain Music |
| Usual Care | Other | The Usual Care control group will continue to be followed in the Memory clinic at intervals determined by their clinician. Participants will complete the pretest and post-test assessments and surveys at baseline and at the end of 5 weeks. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measure 1: Study participation rates
Feasibility of the neurofeedback interventions will be assessed by study participation rates.
Measured: Data will be collected throughout the study enrolment period of three months
Feasibility Measure 2: Survey response rates
Feasibility of the neurofeedback interventions will be assessed by survey response rates.
Measured: Data will be collected throughout the study enrolment and delivery period of six months.
Feasibility Measure 3: Study withdrawal rates
Feasibility of the neurofeedback interventions will be assessed by study withdrawal rates.
Measured: Data will be collected throughout the study enrolment and delivery period of six months.
Creyos Health Cognitive Assessment: Objective measure of cognition
The primary clinical outcome of cognition will be measured objectively using the Creyos Health Cognitive Assessment, an online platform of validated neurocognitive tasks and batteries that have been used in over 300 peer-reviewed studies to measure core elements of cognition. Individual raw scores on a task are compared with a population of individuals of the same gender and age group and presented as standard scores and percentiles and then adjusted to better reflect the individual's true cognitive ability. Scores are classified as average, below average or above average based on the standard score. We will use the 6-task version of the Creyos MCI battery as it appears to be adequate for monitoring and reduces testing time.
Measured: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Feasibility Measure 4: Feasibility of Intervention Measure (FIM)
Feasibility of the neurofeedback interventions will be assessed using the Feasibility of Intervention Measure (FIM) which is a subscale of The Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher feasibility.
Measured: The FIM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session.
Feasibility Measure 5: Acceptability of Intervention Measure (AIM)
Acceptability, of the neurofeedback interventions will be assessed using the Acceptability of Intervention Measure (AIM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher acceptability of the intervention.
Measured: The AIM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session.
Feasibility Measure 6: Intervention Appropriateness Measure (IAM)
Appropriateness of the neurofeedback interventions will be assessed using the Intervention Appropriateness Measure (IAM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher appropriateness of the intervention.
Measured: The IAM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session. Data will be collected throughout the study period of six months
Secondary outcomes (3)
Beck Anxiety Inventory: Anxiety
The Beck Anxiety Inventory consists of 21 items to assess a broad range of emotional, physical, cognitive and behavioural symptoms that represent important dimensions of anxiety. The BAI shows high internal consistency (alpha=.92) and test-retest reliability over 1 week, r(81) = .75. Individual scale items are rated on a scale from 0 to 3. The total score is cauculted by finding the sum of the 21 items. Higher scores indicate higher levels of anxiety.
Measured: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week 5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Beck Depression Inventory: Depression
The Beck Depression Inventory-II (BDI-II) consists of 21 items to assess the intensity of depression in clinical and normal patients over the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression in alignment with the DSM-IV criteria. The BDI-II (Coefficient Alpha = .92) showed improved clinical sensitivity over the BDI (Coefficient Alpha = .86). ndividual scale items are rated on a scale from 0 to 3. The total score is cauculted by finding the sum of the 21 items. Higher scores indicate higher levels of depression.
Measured: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Short-Form Pittsburgh Sleep Quality Index: Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval. Nineteen individual items generate 7 component scores and a global score. The PSQI demonstrates acceptable measures of internal homogeneity, consistency and validity, and distinguishes well between good and poor sleepers. We will use the short form SF-PSQI in this study, a 13-item scale that corresponds to 5 of the 7 components of the original tool. Total scores range from 0 to 21 with higher scores associated with poorer sleep quality.
Measured: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start27 Jan 2025 (estimated)
- Primary completion23 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Principal investigator, Marian Luctkar-Flude, RN, PhD, Queen's University
- Investigators
- Marian Luctkar-Flude, PhD, Principal investigator, Queen's University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762522
- Sponsor's protocol ID
- 65459
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small feasibility study, thus it will not be necessary to share any individual participant data with other researchers.
Publications
Trambaiolli LR, Cassani R, Mehler DMA, Falk TH. Neurofeedback and the Aging Brain: A Systematic Review of Training Protocols for Dementia and Mild Cognitive Impairment. Front Aging Neurosci. 2021 Jun 9;13:682683. doi: 10.3389/fnagi.2021.682683. eCollection 2021.
PubMed 34177558Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Author Correction: Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2019 May;20(5):314. doi: 10.1038/s41583-019-0161-1.
PubMed 30911159Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Practice guideline update summary: Mild cognitive impairment [RETIRED]: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Jan 16;90(3):126-135. doi: 10.1212/WNL.0000000000004826. Epub 2017 Dec 27.
PubMed 29282327McGirr A, Nathan S, Ghahremani M, Gill S, Smith EE, Ismail Z. Progression to Dementia or Reversion to Normal Cognition in Mild Cognitive Impairment as a Function of Late-Onset Neuropsychiatric Symptoms. Neurology. 2022 May 24;98(21):e2132-e2139. doi: 10.1212/WNL.0000000000200256. Epub 2022 Mar 29.
PubMed 35351783Gallagher D, Fischer CE, Iaboni A. Neuropsychiatric Symptoms in Mild Cognitive Impairment. Can J Psychiatry. 2017 Mar;62(3):161-169. doi: 10.1177/0706743716648296.
PubMed 28212495Alzheimer Society. (2024). Mild cognitive impairment. https://alzheimer.ca/en/about-dementia/other-types-dementia/conditions-related-dementia
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Beck Depression Inventory-II (BDI-II). https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-Assessments/Personality-%26-Biopsychosocial/Beck-Depression-Inventory/p/100000159.html?tab=product-details
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Campos da Paz, V.K., & Tomaz, C. (2020). Neurofeedback training on aging: Prospects on maintaining cognitive reserve. In K.F.Shad & K.H. Dogan (Eds.) Neurological and mental disorders. http://dx.doi.org/10.5772/intechopen.90847
Canadian Task Force on Preventive Health Care. (2023). Cognitive impairment: Clinician summary. https://canadiantaskforce.ca/cognitive-impairment-clinician-summary/
Chen Medimo Corp. (2023). NeuroRecovery Training (NRT). https://chenmedimo.org/nrt
Corbo I, Marselli G, Di Ciero V, Casagrande M. The Protective Role of Cognitive Reserve in Mild Cognitive Impairment: A Systematic Review. J Clin Med. 2023 Feb 22;12(5):1759. doi: 10.3390/jcm12051759.
PubMed 36902545Creyos, Canada. (2024). Creyos: Quickly gain validated and powerful brain health insights. https://creyos.com/
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Feasibility and Acceptability of Using Neurofeedback Interventions to Manage Cognitive, Affective and Behavioural Symptoms in Persons with Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06762522
- Acronym / sponsor ID
- 65459
- Conditions
- Mild Cognitive Impairment
- Keywords
- Neurofeedback, Feasibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 7 Jan 2025 (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 goal of this pilot study is to determine the feasibility, acceptability and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI). The main question[s] it aims to answer are: (1) What is the feasibility, acceptability, and appropriateness of using the Nonlinear Dynamical Neurofeedback intervention for persons living with MCI? (2) What is the feasibility, acceptability, and appropriateness of using the Low Energy Neurofeedback System (LENS) intervention for persons living with MCI? (3) What is the feasibility, acceptability, and appropriateness of using the Brain Music neurofeedback intervention for persons living with MCI? (4) What is the potential impact of five weeks of a neurofeedback intervention on cognitive, affective, and behavioural symptoms experienced by persons living with MCI? Participants will be randomly assigned to either the Nonlinear Dynamical (NLD), Low Energy Neurofeedback System (LENS), or Brain Music neurofeedback intervention groups or a control group receiving usual care.
Detailed description
Mild cognitive impairment (MCI) involves more severe memory, language, thinking, or judgment problems than normal aging, often progressing to dementia. Current treatments, both pharmacological and non-pharmacological, show limited benefits, prompting the need for alternative approaches like neurofeedback. Neurofeedback is a non-invasive technique that enhances the central nervous system's flexibility and resilience, potentially boosting cognitive reserve and delaying cognitive decline. This study focuses on three advanced neurofeedback methods: Nonlinear Dynamical Neurofeedback (NLD), Low Energy Neurofeedback System (LENS), and Brain Music. Before conducting a full clinical trial, it's crucial to determine if these methods are feasible and acceptable for people with MCI. This pilot study aims to explore the feasibility, acceptability, and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI).
The study involves a quasi-experimental design with 20 participants recruited from the Providence Care Hospital Memory Clinic in Kingston, Ontario. Participants will be randomly assigned to either the NLD, LENS, or Brain Music intervention groups or a control group receiving usual care. Each intervention will last five weeks, with assessments conducted before and after the intervention period. Clinical outcomes measured include objective cognitive assessments using the Creyos Health Cognitive Assessment. Subjective self-reported measures will include the Short-Form Pittsburgh Sleep Quality Index (SF-PSQI) survey to measure sleep quality, the Beck Depression Inventory (BDI) to measure depressive symptoms, and the Beck Anxiety Inventory (BAI) to measure anxiety. Feasibility and acceptability will be evaluated based on participation rates, survey responses, and withdrawal rates, along with the resources needed for the study. Data analysis will involve repeated measures ANOVAs to identify trends and assess the reliability of the measures used, providing foundational data for future research on neurofeedback's efficacy in managing MCI symptoms This data will inform the design of a larger clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nonlinear dynamical neurofeedback (NLD) | Experimental | Other: Nonlinear dynamical neurofeedback (NLD)The NLD study intervention will consist of 10 sessions of NeurOptimal neurofeedback delivered twice a week over a 5-week period. The intervention will be delivered by a certified NeurOptimal trainer. The average session length is 45 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. |
| Low energy neurofeedback system (LENS) | Experimental | Other: Low energy neurofeedback system (LENS)The LENS study intervention will consist of 5 sessions of LENS neurofeedback delivered by a certified LENS trainer once a week over a 5-week period. The average session length is 15 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. |
| Brain Music | Experimental | Other: Brain MusicThe Brain Music study intervention will consist of a brain mapping data acquisition session to create the personalized music, followed by 5 weekly sessions to adjust the music that participants will listen to at home on a daily basis. Initial data acquisition and weekly sessions will take about 30 minutes. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed. |
| Usual Care | Other | Other: Usual CareThe Usual Care control group will continue to be followed in the Memory clinic at intervals determined by their clinician. Participants will complete the pretest and post-test assessments and surveys at baseline and at the end of 5 weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with mild cognitive impairment (MCI) attending the Memory Clinic at Providence Care Hospital in Kingston, Ontario
Key exclusion criteria (1 listed)
- Adults with cognitive issues related to a psychiatric diagnosis or acute brain injury
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 |
|---|---|---|
| Nonlinear dynamical neurofeedback (NLD)Also: NeurOptimal neurofeedback, Brain trainingNeurOptimal nonlinear dynamical (NLD) neurofeedback brain training works as a detection and monitoring system of changes in cortical patterns within the brain, mirroring the brain activity that can be undermining optimal brain function, providing the brain with the information it needs to make its own adjustments which over time results in the brain functioning more efficiently and effectively. Two scalp sensors at C3 \& C4 and two earclips at tops of ears (reference) and one on the earlobe (ground) are used to read EEG activity which is analyzed by the NeurOptimal software. As participants listen to music through earbuds, information is fed back to the individual by slight interruptions in the music. One session lasts 33.5 minutes. | Other | Nonlinear dynamical neurofeedback (NLD) |
| Low energy neurofeedback system (LENS)Also: Direct neurofeedbackLow energy neurofeedback system (LENS) therapy is an EEG-based direct neurofeedback system that stimulates the brain to reset itself and achieve optimal performance. Therapy consists of delivery of a tiny electromagnetic field carrying the feedback signal down the electrode wires for only one second at each of the chosen electrode sites during every session. Generally, between one and seven of the ordinary electrode sites are utilized during each session. Therapy is adapted to the participant's reactivity/sensitivity and the response of their nervous system. | Other | Low energy neurofeedback system (LENS) |
| Brain MusicAlso: Chen Medimo Corp. (CMC), CMC Brain MusicChen Medimo Corp (CMC) Brain Music neurofeedback analyzes an individual's EEG brainwave patterns and translates them into orchestral music. Listening to this personalized brain music allows the individual to gain self-awareness and rewire and alter their own mental states. The Brain Music protocol requires regular in-person follow-ups for optimal results. Generally, the number of sessions varies based on individual needs and the progress made in response to the CMC Brain Music. A minimum of once a week in-person sessions is recommended for qEEG model updating to accurately track progress. Each session may last 30 minutes. Additionally, participants are advised to listen to their personalised music at least once a day, with a minimum of two listens per session. In general, participants may start to detect a change in their neurodevelopmental or cognitive function in 4-6 weeks. | Other | Brain Music |
| Usual CareAlso: Control groupThe Usual Care control group will be followed in the Memory clinic at intervals determined by their clinician. Usual Care for individuals with mild cognitive impairment (MCI) at the The Memory Clinic consists of inter-professional assessment, diagnosis and recommendations. There are currently no drugs approved to treat MCI. Therapy is aimed at managing treatable causes and contributors including medication side effects, thyroid problems, sleep apnea, vitabim B deficiency, depression, anxiety, and unrecognized or untreated difficulties with hearing or vision. Neurofeedback is not a component of the standard of care. | Other | Usual Care |
Primary outcome
Feasibility Measure 1: Study participation rates
Time frame: Data will be collected throughout the study enrolment period of three months
Feasibility of the neurofeedback interventions will be assessed by study participation rates.
Feasibility Measure 2: Survey response rates
Time frame: Data will be collected throughout the study enrolment and delivery period of six months.
Feasibility of the neurofeedback interventions will be assessed by survey response rates.
Feasibility Measure 3: Study withdrawal rates
Time frame: Data will be collected throughout the study enrolment and delivery period of six months.
Feasibility of the neurofeedback interventions will be assessed by study withdrawal rates.
Creyos Health Cognitive Assessment: Objective measure of cognition
Time frame: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
The primary clinical outcome of cognition will be measured objectively using the Creyos Health Cognitive Assessment, an online platform of validated neurocognitive tasks and batteries that have been used in over 300 peer-reviewed studies to measure core elements of cognition. Individual raw scores on a task are compared with a population of individuals of the same gender and age group and presented as standard scores and percentiles and then adjusted to better reflect the individual's true cognitive ability. Scores are classified as average, below average or above average based on the standard score. We will use the 6-task version of the Creyos MCI battery as it appears to be adequate for monitoring and reduces testing time.
Feasibility Measure 4: Feasibility of Intervention Measure (FIM)
Time frame: The FIM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session.
Feasibility of the neurofeedback interventions will be assessed using the Feasibility of Intervention Measure (FIM) which is a subscale of The Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher feasibility.
Feasibility Measure 5: Acceptability of Intervention Measure (AIM)
Time frame: The AIM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session.
Acceptability, of the neurofeedback interventions will be assessed using the Acceptability of Intervention Measure (AIM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher acceptability of the intervention.
Feasibility Measure 6: Intervention Appropriateness Measure (IAM)
Time frame: The IAM will be completed as part of the follow-up survey at T2, 5 weeks following the last neurofeedback session. Data will be collected throughout the study period of six months
Appropriateness of the neurofeedback interventions will be assessed using the Intervention Appropriateness Measure (IAM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher appropriateness of the intervention.
3 secondary outcomes
Beck Anxiety Inventory: Anxiety
Time frame: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week 5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Beck Depression Inventory: Depression
Time frame: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Short-Form Pittsburgh Sleep Quality Index: Sleep quality
Time frame: Measurement will occur at three time points: (T0) at week 0, immediately before the first neurofeedback session, (T1) at week5, after the last neurofeedback session, and (T2) 5 weeks following the last neurofeedback session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 34177558Trambaiolli LR, Cassani R, Mehler DMA, Falk TH. Neurofeedback and the Aging Brain: A Systematic Review of Training Protocols for Dementia and Mild Cognitive Impairment. Front Aging Neurosci. 2021 Jun 9;13:682683. doi: 10.3389/fnagi.2021.682683. eCollection 2021.
- Background: PubMed 30911159Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Author Correction: Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2019 May;20(5):314. doi: 10.1038/s41583-019-0161-1.
- Background: PubMed 29282327Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Practice guideline update summary: Mild cognitive impairment [RETIRED]: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Jan 16;90(3):126-135. doi: 10.1212/WNL.0000000000004826. Epub 2017 Dec 27.
- Background: PubMed 35351783McGirr A, Nathan S, Ghahremani M, Gill S, Smith EE, Ismail Z. Progression to Dementia or Reversion to Normal Cognition in Mild Cognitive Impairment as a Function of Late-Onset Neuropsychiatric Symptoms. Neurology. 2022 May 24;98(21):e2132-e2139. doi: 10.1212/WNL.0000000000200256. Epub 2022 Mar 29.
- Background: PubMed 28212495Gallagher D, Fischer CE, Iaboni A. Neuropsychiatric Symptoms in Mild Cognitive Impairment. Can J Psychiatry. 2017 Mar;62(3):161-169. doi: 10.1177/0706743716648296.
- BackgroundAlzheimer Society. (2024). Mild cognitive impairment. https://alzheimer.ca/en/about-dementia/other-types-dementia/conditions-related-dementia
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- BackgroundBeck, A.T., Steer, R.A., & Brown, G.K. (1996). Beck Depression Inventory-II (BDI-II). https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-Assessments/Personality-%26-Biopsychosocial/Beck-Depression-Inventory/p/100000159.html?tab=product-details
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- BackgroundCampos da Paz, V.K., & Tomaz, C. (2020). Neurofeedback training on aging: Prospects on maintaining cognitive reserve. In K.F.Shad & K.H. Dogan (Eds.) Neurological and mental disorders. http://dx.doi.org/10.5772/intechopen.90847
- BackgroundCanadian Task Force on Preventive Health Care. (2023). Cognitive impairment: Clinician summary. https://canadiantaskforce.ca/cognitive-impairment-clinician-summary/
- Individual participant dataSharing planned: No. This is a small feasibility study, thus it will not be necessary to share any individual participant data with other researchers.
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
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.
Marian Luctkar-Flude, PhD principal investigator
Queen's University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonlinear dynamical neurofeedback (NLD), Low energy neurofeedback system (LENS) and Brain Music in people with Mild Cognitive Impairment, run by Queen's University at 1 site in Canada.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Jan 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian Luctkar-Flude, PhD (613-888-6335, mfl1@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measure 1: Study participation rates (time frame: Data will be collected throughout the study enrolment period of three months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762522, which also lists 21 linked publications.
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 7 Jan 2025.