Sound and Music Therapy for Mild Cognitive Impairment

Overseen By JUNXIN LI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Schizophrenia, Parkinson's, severe hearing, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sound and Music Therapy for Mild Cognitive Impairment?

Research shows that 40 Hz sensory therapy, which includes sound, has shown promise in improving cognition in Alzheimer's patients, and music therapy has been effective in enhancing cognitive functions and emotional states in individuals with cognitive impairments. ^{1 2 3 4 5}

Is sound and music therapy safe for humans with mild cognitive impairment?

Research shows that 40 Hz sound and music therapy is generally safe and well-tolerated in humans, with no reported side effects in studies involving Alzheimer's and mild cognitive impairment patients. ^{1 6 7 8 9}

How does 40 Hz sound and music therapy differ from other treatments for mild cognitive impairment?

This treatment is unique because it uses non-invasive 40 Hz sound and music therapy to stimulate the brain, which has shown promise in improving cognitive function without side effects. Unlike traditional drug treatments, it involves listening to specific sound frequencies that may enhance brain activity and slow cognitive decline. ^{1 2 10 11 12}

Research Team

JUNXIN LI, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for older adults who have mild cognitive impairment but can still take care of themselves. They shouldn't have dementia, schizophrenia, Parkinson's disease, severe hearing loss, or any serious medical/psychiatric issues that would stop them from following the study.

Inclusion Criteria

I live at home and have memory loss or mild thinking problems.

My organs are working well.

No dementia

Exclusion Criteria

I have been diagnosed with schizophrenia or Parkinson's disease.

I have severe hearing loss.

Presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to 40 Hz music, 40 Hz sound, and music alone interventions in different sequences

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in cognitive function after the intervention

4 weeks

Treatment Details

Interventions

• 40 Hz music
• 40 Hz sound
• Preferred music

Trial Overview The study tests three things: music at a specific frequency (40 Hz), just the sound at this frequency without music, and whatever music the participant likes best. The goal is to see if these sounds improve brain function in those with mild cognitive issues.

Participant Groups

Group I: 3 Experimental Treatment 3 Interventions

this group will be exposed to condition C first, then A, and B

Group II: 2 Experimental Treatment 3 Interventions

this group will be exposed to condition B first, then C, and A

Group III: 1 Experimental Treatment 3 Interventions

this group will be exposed to condition A first, then B, and C

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A non-invasive 40 Hz sensory therapy using light and sound was found to be safe and tolerable in a small group of 27 participants with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD), with 11 completing 6 months of therapy.

Some participants showed cognitive improvements, with 2 out of 4 with subjective complaints and 2 out of 6 with AD improving their Montreal Cognitive Assessment (MOCA) scores, suggesting potential benefits of this therapy that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. McNett, SD., Vyshedskiy, A., Savchenko, A., et al.[2023]

Music therapy has shown promise in improving the quality of life for older adults with cognitive impairments, such as Alzheimer's and Parkinson's diseases, by using personalized music to reduce agitation and enhance memory.

The paper presents a four-level model of how music can affect brain function, which may guide future research and therapeutic strategies in treating neurodegenerative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are We Doing More Than We Know? Possible Mechanisms of Response to Music Therapy. Clements-Cortes, A., Bartel, L.[2020]

A pilot study involving 16 older adults with mild cognitive impairment showed that a 12-week music therapy intervention significantly improved various cognitive functions, including attention, immediate and delayed memory, and executive function.

The study also found improvements in gait parameters, such as gait velocity and stride length, indicating that music therapy may be an effective and innovative approach to enhance both cognitive and physical abilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. Domínguez-Chávez, CJ., Murrock, CJ., Guerrero, PIC., et al.[2019]

A short 60-minute music therapy session significantly reduced stress levels and improved emotional states in 25 patients with mild Alzheimer's disease, as indicated by lower salivary cortisol levels.

The therapy also led to significant decreases in anxiety and depression scores, suggesting that music therapy could be an effective complementary treatment for enhancing emotional well-being in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Music Therapy Improve Anxiety and Depression in Alzheimer's Patients? de la Rubia Ortí, JE., García-Pardo, MP., Iranzo, CC., et al.[2018]

The GENUS device, which uses 40Hz sensory stimulation, was found to be safe and effective in inducing brain entrainment in both cognitively normal individuals and patients with mild Alzheimer's disease (AD) during a Phase 1 feasibility study involving 43 participants.

In a Phase 2A pilot study with 15 patients, chronic daily 40Hz stimulation led to significant improvements in brain health, including reduced hippocampal atrophy and better cognitive performance, suggesting its potential as a novel treatment for AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. Chan, D., Suk, HJ., Jackson, BL., et al.[2023]

Music-based interventions (MBIs) are gaining traction as a non-invasive treatment for dementia-related disorders, but their effectiveness has shown mixed results in clinical studies.

Incorporating non-invasive Gamma-frequency stimulation (40 Hz) into MBIs may enhance their efficacy by targeting multiple aspects of dementia pathology and improving cognitive function, suggesting a promising new approach for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating music-based interventions with Gamma-frequency stimulation: Implications for healthy ageing. Tichko, P., Kim, JC., Large, E., 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]

A 6-month study involving 22 patients with mild to moderate Alzheimer's disease showed that daily 40 Hz gamma sensory stimulation therapy was well tolerated and helped maintain functional abilities, unlike the sham group which experienced a decline.

Patients receiving the active treatment had improved sleep quality, as indicated by reduced nighttime activity, suggesting that gamma sensory stimulation may have beneficial effects on both sleep and cognitive function in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Cimenser, A., Hempel, E., Travers, T., et al.[2021]

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 involving 18 Alzheimer's disease patients across different stages, 40 Hz sound stimulation showed significant improvements in cognitive function compared to visual stimulation, particularly in those with mild and moderate AD.

The results suggest that 40 Hz sound treatment could be a promising new approach for enhancing cognitive function in Alzheimer's patients, warranting further research to explore its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Rhythmic Sensory Stimulation in Alzheimer's Disease: An Exploratory Pilot Study. Clements-Cortes, A., Ahonen, H., Evans, M., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Are We Doing More Than We Know? Possible Mechanisms of Response to Music Therapy. [2020]

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

Dual-Task-Based Music Therapy to Improve Executive Functioning of Elderly Patients with Early Stage Alzheimer's Disease: A Multiple Case Study. [2023]

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

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. [2019]

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

Does Music Therapy Improve Anxiety and Depression in Alzheimer's Patients? [2018]

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

Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Integrating music-based interventions with Gamma-frequency stimulation: Implications for healthy ageing. [2023]

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

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

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

Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. [2021]

10. 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]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Rhythmic Sensory Stimulation in Alzheimer's Disease: An Exploratory Pilot Study. [2018]

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

40-Hz steady state response in Alzheimer's disease and mild cognitive impairment. [2022]