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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and user-friendliness of three neurofeedback techniques for individuals with mild cognitive impairment (MCI), which affects memory and thinking. Participants will engage with one of three methods: listening to personalized music (Brain Music), short sessions of brain wave feedback (Low Energy Neurofeedback System), or a more dynamic brain training (Nonlinear Dynamical Neurofeedback). The study seeks to determine if these methods can improve cognitive, emotional, and behavioral symptoms. Individuals diagnosed with MCI who attend the Memory Clinic in Kingston, Ontario, may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to explore innovative treatments that could enhance their quality of life.

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 prior data suggests that these neurofeedback interventions are safe for individuals with mild cognitive impairment?

A previous study found that treatments like the Low Energy Neurofeedback System (LENS) were generally easy for people to handle. Only a few studies mentioned any side effects, suggesting it is safe for most people. Research has shown that LENS can quickly help with thinking and mood problems, making it a promising option for those with mild memory issues.

For the Brain Music treatment, studies have shown that music therapy is safe and can improve thinking skills. It is often used as a non-drug treatment for people with dementia and other brain-related conditions, demonstrating its safety and potential benefits.

Research on Nonlinear Dynamical Neurofeedback (NLD) suggests it is well-tolerated. Like other neurofeedback methods, it is non-invasive, meaning it doesn't involve surgery or drugs. This makes it a safe choice for managing symptoms like anxiety and mood changes.

Overall, these treatments are safe and have been shown to help with various thinking and emotional issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these neurofeedback treatments for mild cognitive impairment because they offer unique, personalized approaches that differ from the standard care, which typically involves medication and cognitive therapy. The Low Energy Neurofeedback System (LENS) uses subtle energy patterns to potentially recalibrate brain function in short, 15-minute sessions, offering a non-invasive and time-efficient alternative. Meanwhile, Brain Music transforms brainwave patterns into personalized music, which participants can listen to daily at home, making it a novel and accessible treatment option. Lastly, Nonlinear Dynamical Neurofeedback (NLD) aims to optimize brain activity through specialized sessions, promising a dynamic and adaptable treatment method. Each of these approaches taps into the brain's ability to reorganize itself, providing hope for more effective and individualized care.

What evidence suggests that this trial's neurofeedback interventions could be effective for mild cognitive impairment?

Research has shown that neurofeedback can positively affect thinking skills in people with mild cognitive impairment (MCI). Studies found that 84% of patients using neurofeedback experienced significant improvements in their thinking abilities. In this trial, participants may receive the Low Energy Neurofeedback System (LENS), which improved memory for up to 30 days. Another group will receive Brain Music therapy, which enhanced thinking skills and mood in older adults with MCI. Participants in a different arm will receive Nonlinear Dynamical Neurofeedback, which also improved thinking abilities, suggesting it might help slow cognitive decline. These findings support the potential of these neurofeedback methods to manage symptoms of MCI. ^{6 7 8 9 10}

Who Is on the Research Team?

Marian Luctkar-Flude, PhD

Principal Investigator

Queen's University, School of Nursing

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

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Effectiveness of cognitive stimulation for individuals with ... Our findings suggest a significant positive impact of CS on cognitive function among individuals with MCI. CS encourages the active involvement of individuals ...

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The effect of music therapy on cognitive functions in patients ... The results showed that compared to different control groups, there is an improvement in cognitive functions after music therapy application.

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The effect of receptive music therapy on older adults with ... Receptive music therapy intervention significantly improved cognitive function and reduced depressive symptoms in older adults with MCI.

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A Qualitative Exploration of 40 Hz Sound and Music ... This study highlights the potential of integrating 40 Hz sound with personalized music to offer a more acceptable 40 Hz auditory intervention for cognition in ...

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A systematic review on effect of music intervention ... Music therapy, an emerging field in music cognition [19] is safe for the brain injured patients [20] which improves cognitive ability and enhances the quality ...

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Music and Dementia: An Overview - - Practical Neurology These studies suggest that music training may have a protective effect in the face of age-related mild cognitive changes and can occur even ...

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