Gamma-Music Therapy for Alzheimer's Disease

(NUGammaMBI Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Must be taking: Cholinesterase inhibitors, Memantine

Disqualifiers: Stroke, Psychiatric disorders, Substance abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Gamma-Music Based Intervention, which combines special light therapy with music to help slow Alzheimer's Disease. The researchers aim to determine how this treatment affects brain activity, its enjoyment for patients, and who might benefit most. Participants will receive either the real treatment with gamma lights or a similar one with control lights for comparison. Individuals with mild Alzheimer's Disease who can still manage daily tasks might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial requires that participants stay on stable doses of any medications with psychotropic effects (like cholinesterase inhibitors, memantine, and antidepressants) for at least 3 months before joining. So, you won't need to stop taking your current medications if they are stable.

What prior data suggests that this gamma-music-based intervention is safe for participants with mild Alzheimer's Disease?

Research has shown that gamma rhythm stimulation is generally safe and well-tolerated for people with Alzheimer's disease. In several studies, patients who experienced sensory stimulation, such as lights flashing at gamma frequencies, reported no serious side effects. Reviews of gamma stimulation highlight its safety and benefits for improving thinking and memory in Alzheimer's patients. This suggests that the gamma-music-based approach, which combines music with these special lights, is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike current Alzheimer's treatments that primarily focus on slowing cognitive decline using medications like cholinesterase inhibitors and NMDA receptor antagonists, the Gamma-Music Based Intervention offers a unique approach. Researchers are excited about this treatment because it combines music therapy with gamma light stimulation, which is thought to enhance brain wave activity associated with memory and attention. This non-invasive method could potentially improve cognitive function without the side effects common with drug therapies, offering a fresh avenue for managing Alzheimer's symptoms.

What evidence suggests that this gamma-music therapy is effective for Alzheimer's Disease?

This trial will compare a Gamma-Music Based Intervention with a control intervention. Research has shown that gamma rhythm stimulation may help treat brain disorders like Alzheimer's. One study found that 40Hz stimulation improved thinking skills, helped prevent brain cell loss, and increased brain activity. Combining this with music might enhance the treatment by targeting different brain areas simultaneously. The approach uses lights and music at a gamma frequency to make the therapy more enjoyable and effective. This combined method could potentially slow Alzheimer's by boosting brain activity and engagement. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 55-90 with mild Alzheimer's Disease, confirmed by specific memory and cognitive tests. They must be medically stable, not have a history of substance or alcohol abuse, and be on steady medication for at least three months. A study partner to provide information about the participant is required.

Inclusion Criteria

Participants who are medically stable

Participants with a CDR global score of 0.5 (with a memory box score of 0.5 or 1)

Participants with a study partner who is able to provide collateral information about the participant

Exclusion Criteria

Participants who fail audiometric screening

Participants with contraindications to MRI scanning

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week music-based intervention with gamma lights or control lights

8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gamma-Music Based Intervention

Trial Overview The trial studies a new brain-stimulation tool that combines gamma-frequency lights with self-selected music (gamma-MBI) to see if it can influence brain activity and delay Alzheimer's progression. It aims to create an enjoyable intervention protocol.

How Is the Trial Designed?

Group I: Gamma Experimental Treatment 1 Intervention

8-week music-based intervention with gamma lights

Group II: Control Placebo Group 1 Intervention

8-week music-based intervention with control lights

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Published Research Related to This Trial

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]

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]

Active music-making can serve as an effective therapy for Alzheimer's patients, helping to maintain cognitive functions and improve quality of life through social interaction and self-expression.

Music therapy may reduce the need for tranquilizers and hypnotics, promoting mood improvement and enhancing mental processes, suggesting it could be a valuable part of rehabilitation strategies for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's disease: rhythm, timing and music as therapy. Aldridge, D.[2022]

A study involving 10 patients with mild cognitive impairment due to Alzheimer's disease demonstrated that daily 1-hour sessions of gamma flicker stimulation (40 Hz) were safe, well-tolerated, and adhered to over 4 to 8 weeks.

Preliminary results indicated that this gamma flicker stimulation may positively influence neural activity and immune factors in the nervous system, suggesting potential benefits for further research in Alzheimer's treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. He, Q., Colon-Motas, KM., Pybus, AF., et al.[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]

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]

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]

A pilot project involving 14 patients with probable Alzheimer's disease and their caregivers showed that music therapy led to significant improvements in various emotional and social aspects, as reported by caregivers.

Statistical analysis revealed notable improvements in multiple standardized tests measuring dementia symptoms, agitation, caregiver burden, and depression, indicating the potential efficacy of music therapy for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy with Alzheimer's patients and their family caregivers: a pilot project. Brotons, M., Marti, P.[2022]

Music therapy shows potential benefits for mood and cognition in Alzheimer's patients, but existing studies lack rigorous methodological design, making it hard to generalize the results.

There is insufficient neurophysiological and neurochemical evidence to fully understand how music therapy works, leading to a reliance on anecdotal evidence rather than solid scientific backing for its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy in Alzheimer's disease: is an evidence-based approach possible?]. Riello, R., Frisoni, GB.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9899516/

Integrating music-based interventions with Gamma-frequency ... We theorize that combining MBIs with Gamma-frequency stimulation could increase the therapeutic power of MBIs by simultaneously targeting multiple biomarkers ...

2. reporter.nih.gov reporter.nih.gov/project-details/10703506

Gamma-Music Based Intervention for Mild Alzheimer's ... We will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention.

3. news.mit.edu news.mit.edu/2024/evidence-gamma-rhythm-stimulation-can-treat-neurological-disorders-emerging-0118

Evidence that gamma rhythm stimulation can treat ... Finally, a 40Hz stimulation clinical study using TMS in 37 patients found improvements in cognition, prevention of brain atrophy, and increased ...

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1287018/full

Gamma music: a new acoustic stimulus for ... In this study, we proposed a new form of gamma stimulation, called gamma music, combining 40 Hz auditory stimuli and music.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ejn.15059

Integrating music‐based interventions with Gamma ... These findings suggest that the efficacy of MBIs could, in theory, be enhanced by incorporating Gamma-frequency stimulation into current MBI ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15459683251360733

The Effects and Safety of Gamma Rhythm Stimulation on ... This review highlights the safety and benefits of gamma stimulation for cognitive improvement in patients with AD, with sensory stimulation ...

7. researchgate.net researchgate.net/publication/391248789_Diary_Analysis_of_an_RCT_Natural_Language_Analyses_of_Gamma-Music-Based_Intervention

Diary Analysis of an RCT: Natural Language Analyses ... We theorize that combining MBIs with Gamma‐frequency stimulation could increase the therapeutic power of MBIs by simultaneously targeting ...