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?

The study will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention for participants with mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and behavioral intervention by combining music therapy with gamma- band neurostimulation, the present project aims to find a sustainable intervention that delays the progression of AD.

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.

Is Gamma-Music Therapy safe for humans?

Research suggests that Gamma-Music Therapy, which combines music-based interventions with Gamma-frequency stimulation, is generally safe for humans. Studies have shown that non-invasive Gamma-frequency stimulation, such as auditory stimulation at 40 Hz, does not require surgery and has been used safely in dementia patients, contributing to mood improvements and maintenance of cognitive function. ^{1 2 3 4 5}

How is Gamma-Music Therapy different from other treatments for Alzheimer's disease?

Gamma-Music Therapy is unique because it combines music-based interventions with Gamma-frequency stimulation, which is a non-invasive method that uses sound waves at a specific frequency (40 Hz) to potentially improve brain function. This approach aims to enhance the therapeutic effects of music by targeting multiple aspects of brain activity related to learning and memory, which is different from traditional treatments that may not address these specific neural mechanisms. ^{1 2 4 6 7}

What data supports the effectiveness of Gamma-Music Therapy for Alzheimer's Disease?

Research suggests that combining music-based interventions with Gamma-frequency stimulation may improve cognitive function and mood in Alzheimer's patients. Studies have shown that Gamma-frequency stimulation can help maintain cognition and enhance mood, while music therapy can improve quality of life and reduce symptoms like agitation and anxiety. ^{1 2 4 8 9}

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]

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]

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]

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]

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 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]

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]

Citations

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

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

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

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

3. Italy pubmed.ncbi.nlm.nih.gov

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

4. France pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

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

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

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

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

A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. [2022]

8. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in neurological rehabilitation settings. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Music therapy with Alzheimer's patients and their family caregivers: a pilot project. [2022]