Neurofeedback for Mild Cognitive Impairment

Overseen By Sarah Moore-Vasram, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kingston Health Sciences Centre

Disqualifiers: Psychiatric diagnosis, Acute brain injury

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Brain Music, Low Energy Neurofeedback System, Nonlinear Dynamical Neurofeedback for mild cognitive impairment?

Research shows that neurofeedback training can improve memory performance in people with mild cognitive impairment, and these benefits may last beyond the training period. Additionally, neurofeedback has been shown to enhance cognitive functions in the elderly, suggesting its potential usefulness for addressing cognitive decline. ^{1 2 3 4 5}

Is neurofeedback safe for humans?

Neurofeedback, a non-invasive method that helps people regulate their brain activity, has been studied in various forms and is generally considered safe for humans. Studies have shown it can improve cognitive functions without significant adverse effects, making it a promising tool for conditions like mild cognitive impairment. ^{4 6 7 8 9}

How does the treatment 'Neurofeedback for Mild Cognitive Impairment' differ from other treatments for this condition?

This treatment is unique because it uses neurofeedback, a method that involves training individuals to change their brain activity using real-time feedback from their brainwaves (EEG signals). Unlike other treatments, it focuses on enhancing specific brainwave patterns to improve memory and cognitive function, and it does not rely on medication. ^{3 4 10 11 12}

Research Team

Marian Luctkar-Flude, PhD

Principal Investigator

Queen's University, School of Nursing

Eligibility Criteria

This trial is for individuals with Mild Cognitive Impairment (MCI). Participants should be willing to undergo neurofeedback interventions or receive usual care. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have mild memory problems and am seeing a doctor at Providence Care Hospital.

Exclusion Criteria

I have cognitive issues due to a psychiatric condition.

I have cognitive issues due to a recent brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the neurofeedback interventions (NLD, LENS, or Brain Music) or usual care over a 5-week period

5 weeks

5 sessions (in-person) for LENS and Brain Music, 10 sessions (in-person) for NLD

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Follow-up assessments conducted

Treatment Details

Interventions

• Brain Music
• Low Energy Neurofeedback System
• Nonlinear Dynamical Neurofeedback

Trial Overview The study tests the feasibility, acceptability, and impact of three neurofeedback techniques—Nonlinear Dynamical Neurofeedback (NLD), Low Energy Neurofeedback System (LENS), and Brain Music—compared to usual care in managing MCI symptoms.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

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.

Group II: Nonlinear dynamical neurofeedback (NLD) Experimental Treatment 1 Intervention

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.

Group III: Low energy neurofeedback system (LENS) Experimental Treatment 1 Intervention

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.

Group IV: Brain Music Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Kingston Health Sciences Centre

Lead Sponsor

Trials

312

Recruited

112,000+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Findings from Research

In a pilot study involving 11 participants with mild cognitive impairment (MCI), neurofeedback training led to significant improvements in memory performance after ten 30-minute sessions over 5 weeks.

The benefits of neurofeedback on memory were maintained for 30 days after training, suggesting that this intervention may be a promising approach for enhancing cognitive function in individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback Improves Memory and Peak Alpha Frequency in Individuals with Mild Cognitive Impairment. Lavy, Y., Dwolatzky, T., Kaplan, Z., et al.[2022]

In a study involving 105 older adults, including those with mild cognitive impairment (MCI), Alzheimer's disease (AD), and healthy controls, it was found that individuals with MCI maintained better functional connectivity between auditory and reward systems compared to those with AD.

The preserved connectivity in MCI suggests that music-based interventions could be particularly beneficial for this group, as they may still engage the brain's reward pathways effectively, motivating further research into MBIs for early-stage neurodegeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resting-State Connectivity of Auditory and Reward Systems in Alzheimer's Disease and Mild Cognitive Impairment. Wang, D., Belden, A., Hanser, SB., et al.[2020]

Gamma entrainment through non-invasive auditory stimulation at 40 Hz has shown potential in enhancing beta amyloid uptake and improving cognitive symptoms in Alzheimer's disease, making it a promising therapeutic approach.

A study involving 13 elderly participants with memory complaints recorded EEG signals during auditory stimulation, providing valuable data for understanding brain oscillatory activity and its implications for dementia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset. Lahijanian, M., Sedghizadeh, MJ., Aghajan, H., et al.[2022]

In a pilot study involving 20 elderly patients with mild cognitive impairment (MCI), sensorimotor (SMR)/theta neurofeedback training over 10 weeks led to significant improvements in cognitive assessments, including the Montreal Cognitive Assessment and the Wechsler Adult Intelligence Scale.

The training also resulted in increased EEG theta and alpha power, indicating enhanced brain activity, with these improvements sustained at a 1-month follow-up, suggesting that neurofeedback could be a promising non-invasive method for cognitive rehabilitation in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Marlats, F., Bao, G., Chevallier, S., et al.[2020]

Neurofeedback (NF) has been shown to enhance cognitive functions like attention and working memory, particularly in children with ADHD, and there is growing evidence that it can also benefit older adults by helping their brain function more like that of younger individuals.

Recent advancements in technology, such as wireless brain activity recording and machine learning, are paving the way for more effective NF training, offering hope for improving cognitive performance and combating age-related cognitive decline in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tuning Up the Old Brain with New Tricks: Attention Training via Neurofeedback. Jiang, Y., Abiri, R., Zhao, X.[2020]

Neurofeedback, which provides real-time sensory rewards based on brain activity, shows promise in improving memory and cognition in both healthy young and older adults, although training typically requires multiple weeks with several sessions per week.

Despite the overall positive trend in memory improvement, individual responses to neurofeedback can vary significantly, with some individuals not benefiting from the training, highlighting the need for further research into psychological factors and personalized approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharpening Working Memory With Real-Time Electrophysiological Brain Signals: Which Neurofeedback Paradigms Work? Jiang, Y., Jessee, W., Hoyng, S., et al.[2023]

A pilot study involving 16 specialists showed that using EEG-based neurofeedback to control the loudness of music significantly reduced stress and improved mental and emotional well-being compared to simply listening to music.

The method demonstrated the potential for personalized music therapy, as it tailored the music experience to the individual's EEG signals, leading to more effective stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Coping Via Musical Neurofeedback. Alexander, F.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A game-based neurofeedback training system to enhance cognitive performance in healthy elderly subjects and in patients with amnestic mild cognitive impairment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Critical validation studies of neurofeedback. [2009]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurofeedback Training Based on Motor Imagery Strategies Increases EEG Complexity in Elderly Population. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Neurofeedback Improves Memory and Peak Alpha Frequency in Individuals with Mild Cognitive Impairment. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Resting-State Connectivity of Auditory and Reward Systems in Alzheimer's Disease and Mild Cognitive Impairment. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Tuning Up the Old Brain with New Tricks: Attention Training via Neurofeedback. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of Visual and Auditory Modalities for Upper-Alpha EEG-Neurofeedback. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Brain Function State During Mild Cognitive Impairment Based on Weighted Multiple Multiscale Entropy. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Sharpening Working Memory With Real-Time Electrophysiological Brain Signals: Which Neurofeedback Paradigms Work? [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Stress Coping Via Musical Neurofeedback. [2022]