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NCT Number: NCT06762522

Exploring Feasibility, Acceptability and Impact of Using Neurofeedback with 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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with mild cognitive impairment (MCI) attending the Memory Clinic at Providence Care Hospital in Kingston, Ontario

Exclusion criteria

  • Adults with cognitive issues related to a psychiatric diagnosis or acute brain injury

Treatment and study plan

Nonlinear dynamical neurofeedback (NLD)

Other

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.

Other names: NeurOptimal neurofeedback, Brain training

Low energy neurofeedback system (LENS)

Other

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.

Other names: Direct neurofeedback

Brain Music

Other

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.

Other names: Chen Medimo Corp. (CMC), CMC Brain Music

Usual Care

Other

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.

Other names: Control group

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian Luctkar-Flude, PhD

CONTACT

[email protected]

613-888-6335

Sarah Moore-Vasram, PhD

CONTACT

[email protected]

613-483-3872

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Providence Health & Services

Registry information

Official study title

Exploring Feasibility and Acceptability of Using Neurofeedback Interventions to Manage Cognitive, Affective and Behavioural Symptoms in Persons with Mild Cognitive Impairment

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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