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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Nonlinear dynamical neurofeedback (NLD); Other: Low energy neurofeedback system (LENS); Other: Brain Music; Other: 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian Luctkar-Flude, PhD; Phone Number: 613-888-6335; Email: mfl1@queensu.ca
• Study Contact Backup: Name: Sarah Moore-Vasram, PhD; Phone Number: 613-483-3872; Email: moorevas@providencecare.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care Hospital
      • Contact: Sarah Moore-Vasram; Phone Number: 53540 613-544-4900; Email: moorevas@providencecare.ca
      • Contact: Sarah Walker; Phone Number: 613-484-3249; Email: walker.s@queensu.ca
      • Contact: Sarah Moore-Vasram

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Nonlinear dynamical neurofeedback (NLD); 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: Brain training; NeurOptimal neurofeedback
Experimental: 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.	Other: Low energy neurofeedback system (LENS); 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
Experimental: Brain Music; 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; 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
Other: Usual Care; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: Kingston Health Sciences Centre
• Collaborators: Providence Health & Services
• Investigators: Principal Investigator: Marian Luctkar-Flude, PhD, Queen's University, School of Nursing

Publications and helpful links

General Publications

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• 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.
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
• 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.
• 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: 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.
• 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.
• Sitaram 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.
• McGirr 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.
• Gallagher D, Fischer CE, Iaboni A. Neuropsychiatric Symptoms in Mild Cognitive Impairment. Can J Psychiatry. 2017 Mar;62(3):161-169. doi: 10.1177/0706743716648296.
• Alzheimer Society. (2024). Mild cognitive impairment. https://alzheimer.ca/en/about-dementia/other-types-dementia/conditions-related-dementia
• Beck, 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
• 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
• 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.
• Creyos, Canada. (2024). Creyos: Quickly gain validated and powerful brain health insights. https://creyos.com/
• Famodu OA, Barr ML, Holaskova I, Zhou W, Morrell JS, Colby SE, Olfert MD. Shortening of the Pittsburgh Sleep Quality Index Survey Using Factor Analysis. Sleep Disord. 2018 Apr 12;2018:9643937. doi: 10.1155/2018/9643937. eCollection 2018.
• Fitzpatrick-Lewis D, Warren R, Ali MU, Sherifali D, Raina P. Treatment for mild cognitive impairment: a systematic review and meta-analysis. CMAJ Open. 2015 Dec 1;3(4):E419-27. doi: 10.9778/cmajo.20150057. eCollection 2015 Oct-Dec.
• Fydrich, T., Dowdall, D., & Chambless, D.L. (1992). Reliability and validity of the Beck Anxiety Inventory. Journal of Anxiety Disorders, 6(1), 55-61. https://doi.org/10.1016/0887-6185(92)90026-4
• 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
• Zengar Institute Inc. (2024). NeurOptimal® Brain Training eBook. https://neuroptimal.com/discover-neuroptimal-ebook/

Study record dates

Study Major Dates

• Study Start (Estimated): January 27, 2025
• Primary Completion (Estimated): December 23, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Neurofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 65459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small feasibility study, thus it will not be necessary to share any individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No