Exploring Feasibility, Acceptability and Impact of Using Neurofeedback with Persons with Mild Cognitive Impairment

NCT06762522 | Not Yet Recruiting

• 1 other identifier: 65459
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Mild Cognitive Impairment

Keywords

Neurofeedback; Feasibility

Outcome Measures

Primary Outcomes (7)

• Feasibility Measure 1: Study participation rates

  Feasibility of the neurofeedback interventions will be assessed by study participation rates.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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.

Study Arms (4)

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.

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.

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.

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.

Other: Usual Care

Interventions

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.

Also known as: NeurOptimal neurofeedback, Brain training

Nonlinear dynamical neurofeedback (NLD)

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.

Also known as: Direct neurofeedback

Low energy neurofeedback system (LENS)

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.

Also known as: Chen Medimo Corp. (CMC), CMC Brain Music

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.

Also known as: Control group

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead
• Providence Health & Services: collaborator

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location

Related Publications (21)

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• Petersen 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.

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  BACKGROUND

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• Campos 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

  BACKGROUND

• Canadian Task Force on Preventive Health Care. (2023). Cognitive impairment: Clinician summary. https://canadiantaskforce.ca/cognitive-impairment-clinician-summary/

  BACKGROUND

• Chen Medimo Corp. (2023). NeuroRecovery Training (NRT). https://chenmedimo.org/nrt

  BACKGROUND

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• Creyos, Canada. (2024). Creyos: Quickly gain validated and powerful brain health insights. https://creyos.com/

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  BACKGROUND

• Ochs, L. (2006). The low energy neurofeedback system (LENS): theory, background, and introduction. Journal of Neurotherapy, 10(2-3), 5-39. https://doi.org/10.1300/J184v10n02_02

  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training; Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marian Luctkar-Flude, PhD

  Queen's University, School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marian Luctkar-Flude, PhD

CONTACT

613-888-6335; mfl1@queensu.ca

Sarah Moore-Vasram, PhD

CONTACT

613-483-3872; moorevas@providencecare.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: January 7, 2025
• Study Start: January 27, 2025
• Primary Completion: December 23, 2025
• Study Completion: January 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)