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

Official title

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

Overview

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.

Interventions

• 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 (gro
• 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
• 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
• 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, an

Primary outcome measures

• Feasibility Measure 1: Study participation rates [Time frame: Data will be collected throughout the study enrolment period of three months]
• Feasibility Measure 2: Survey response rates [Time frame: Data will be collected throughout the study enrolment and delivery period of six months.]
• Feasibility Measure 3: Study withdrawal rates [Time frame: Data will be collected throughout the study enrolment and delivery period of six months.]
• 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.]
• 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 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.]
• 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]

Secondary outcome measures (3)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Canada · 1 center

• Providence Care Hospital — Kingston

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. PMID 34177558
• 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. PMID 30911159
• 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.000 PMID 29282327
• 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. PMID 35351783
• 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. PMID 28212495
• Alzheimer 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. PMID 3204199
• 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

Identifiers

NCT: NCT06762522 · 65459

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗