Musical Stimulation for Aging

(Multimodal Trial)

Overseen By Psyche Loui, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Must not be taking: Cholinesterase inhibitors, Psychotropic

Disqualifiers: Dementia, Parkinson's, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Stage I randomized, sham-controlled trial on the effects of multimodal musical stimulation on working memory in aging. Neurologically healthy older and younger adults will be tested on working memory and electroencephalography in the first randomized controlled trial of music as a form of brain stimulation, with multimodal musical stimulation and control stimulation conditions. Results will test the causal role of oscillatory mechanisms of the brain on cognition, and will lay the groundwork to the first musical, neurophysiologically targeted, brain-stimulation device for reversing cognitive decline in aging.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not have recently changed the dosage of cholinesterase inhibitors or psychotropic medication. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Multimodal Musical Stimulation, Music-Coupled Gamma-Band Stimulation for aging?

Research shows that gamma-band stimulation, which is part of this treatment, can improve cognitive symptoms in dementia patients and enhance brain activity. Additionally, music-based therapies have been effective in improving motor skills and mood in various neurological conditions, suggesting potential benefits for aging-related cognitive and emotional health. ^{1 2 3 4 5}

Is musical stimulation safe for humans?

Research on non-invasive musical stimulation, like gamma-band auditory stimulation, suggests it is generally safe for humans, as it does not require surgery and has been used in studies with elderly participants and dementia patients without reported safety issues. ^{2 3 4 6 7}

How is Multimodal Musical Stimulation different from other treatments for aging?

Multimodal Musical Stimulation is unique because it uses a combination of music and gamma-band auditory stimulation to enhance brain activity, which can improve cognitive functions in aging individuals. Unlike other treatments, it is non-invasive and leverages the natural engagement of the brain's auditory and reward systems, potentially offering a novel way to support healthy aging without the need for medication or surgery. ^{3 7 8 9 10}

Research Team

Psyche Loui, PhD

Principal Investigator

Northeastern University

Eligibility Criteria

This trial is for older and younger adults with normal or corrected vision, mild or no hearing loss, no recent neurological/psychiatric disorders, and not on medication affecting cognition/music response. Those with moderate/severe hearing loss, uncorrectable visual impairment, unstable medication for cognition, major neurologic conditions or serious health issues are excluded.

Inclusion Criteria

I am not on medication that affects my thinking or how I react to music.

I have not had recent mental health or neurological issues.

I have mild or no hearing loss.

Exclusion Criteria

Recent history of serious physical trauma

I have moderate to severe hearing loss.

I recently changed my dose of medication for brain function or mood.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multimodal musical stimulation and control stimulation conditions to test the effects on working memory and electroencephalography.

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Multimodal Musical Stimulation

Trial Overview The study investigates the impact of multimodal musical stimulation versus sham (control) on working memory in aging individuals. It's a Stage I randomized controlled trial that also examines brain activity through electroencephalography to see if music can reverse cognitive decline.

Participant Groups

Group I: Older Adults Gamma (OAg) Experimental Treatment 1 Intervention

The assignment of older adults to OA and OAg will be randomized. The within-subjects factor of stimulation modality includes 2 levels, to be administered in counterbalanced order: Visual (V, i.e., lights-only) and Audiovisual (AV, i.e., music-plus-lights). Each subject will be aware that they are receiving V and AV stimulation, and thus infer that we are comparing these two forms of stimulation and therefore assessing the effects of music. However, and important to the design of this study, all subjects will be blinded with respect to their group assignment; i.e., they will not know, until post-study debriefing, about the other arms of the study, and that the gamma-band stimulation is an active ingredient of the intervention.

Group II: Older Adults (OA) Placebo Group 1 Intervention

The assignment of older adults to OA and OAg will be randomized. The within-subjects factor of stimulation modality includes 2 levels, to be administered in counterbalanced order: Visual (V, i.e., lights-only) and Audiovisual (AV, i.e., music-plus-lights). Each subject will be aware that they are receiving V and AV stimulation, and thus infer that we are comparing these two forms of stimulation and therefore assessing the effects of music. However, and important to the design of this study, all subjects will be blinded with respect to their group assignment; i.e., they will not know, until post-study debriefing, about the other arms of the study, and that the gamma-band stimulation is an active ingredient of the intervention.

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Findings from Research

In a study involving 32 stroke patients, music-supported therapy significantly improved both fine and gross motor skills, enhancing speed, precision, and smoothness of movements over 15 sessions in 3 weeks.

Electrophysiological measures indicated that this therapy led to better cortical connectivity and activation of the motor cortex, suggesting that music-supported therapy not only aids motor recovery but also promotes neural reorganization after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Altenmüller, E., Marco-Pallares, J., Münte, TF., et al.[2009]

Music-based interventions (MBIs) engage various brain circuits and show potential therapeutic benefits for different health conditions, as supported by research from the National Institutes of Health.

Utilizing advanced technologies like human brain imaging and animal models, researchers can analyze how MBIs affect motor, emotional, and cognitive functions, paving the way for more effective evidence-based applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. Chen, WG., Iversen, JR., Kao, MH., et al.[2023]

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]

Neurologic music therapy utilizes music to help patients with nervous system disorders by activating brain processes that can improve non-musical functions, making it a valuable alternative treatment.

Clinical studies show that rehabilitation incorporating music significantly outperforms traditional methods without music, particularly in treating conditions like stroke, brain injury, and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in neurological rehabilitation settings. Galińska, E.[2017]

In a year-long study involving three case studies, gamma stimulation using 40 Hz auditory sound significantly helped maintain cognitive function and improve mood in participants with Alzheimer's disease or mild cognitive impairment.

The therapy was administered through a vibroacoustic chair for 30 minutes, five times a week, suggesting a structured approach that may be beneficial, but further research is needed to fully integrate this intervention into dementia care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. Clements-Cortes, A., Bartel, L.[2023]

In a study involving three chronic stroke patients, Music-Supported Therapy was found to enhance auditory-motor interaction, as indicated by similar neural beta-band activity during both listening and motor tasks.

Post-training assessments showed a significant decrease in beta activity after tone onset and improvements in arm and hand skills, suggesting that music-based rehabilitation can effectively support motor recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in neuromagnetic beta-band oscillation after music-supported stroke rehabilitation. Fujioka, T., Ween, JE., Jamali, S., et al.[2016]

An 8-week personalized music-based intervention (MBI) in cognitively unimpaired older adults led to significant changes in brain connectivity, particularly between auditory regions and the medial prefrontal cortex, suggesting a neural mechanism for the benefits of music on healthy aging.

Participants' ratings of music liking and familiarity influenced brain activation in auditory and reward networks, indicating that personal engagement with music can enhance the effectiveness of MBIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal changes in auditory and reward systems following receptive music-based intervention in older adults. Quinci, MA., Belden, A., Goutama, V., et al.[2023]

In a study investigating auditory stimulation methods, 40 Hz sinusoidal sounds produced the strongest neural response in the prefrontal region when participants' eyes were closed, suggesting enhanced cognitive engagement.

The use of 40 Hz square wave sounds was found to suppress alpha rhythms, indicating a potential new approach to auditory entrainment that could improve cognitive performance and help prevent cerebral atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of the neural response during 40 Hz auditory entrainment in closed-eye state in human prefrontal region. Han, C., Zhao, X., Li, M., et al.[2023]

In a study examining neural entrainment to musical rhythms using EEG, both younger and older adults showed strong phase-locking to musical pulse, indicating preserved rhythmic processing in aging populations.

The findings suggest that self-selected music can be used in interventions to enhance cognitive aging, as older adults maintain similar neural responses to musical rhythms as younger adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Entrainment to Musical Pulse in Naturalistic Music Is Preserved in Aging: Implications for Music-Based Interventions. Tichko, P., Page, N., Kim, JC., et al.[2023]

A 3-month music training program significantly reduced theta power associated with response suppression in older adults, indicating improved executive control mechanisms as measured by high-density EEG during a visual task.

In contrast, visual art training and a control group showed no significant changes, highlighting the unique neuroplastic effects of music interventions on brain activity related to cognitive control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music training modulates theta brain oscillations associated with response suppression. Lu, J., Moussard, A., Guo, S., et al.[2023]

References

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

Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. [2009]

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

Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in neurological rehabilitation settings. [2017]

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

Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. [2023]

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

Changes in neuromagnetic beta-band oscillation after music-supported stroke rehabilitation. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Longitudinal changes in auditory and reward systems following receptive music-based intervention in older adults. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancement of the neural response during 40 Hz auditory entrainment in closed-eye state in human prefrontal region. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Entrainment to Musical Pulse in Naturalistic Music Is Preserved in Aging: Implications for Music-Based Interventions. [2023]

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

Music training modulates theta brain oscillations associated with response suppression. [2023]