60 Participants Needed

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

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.12345

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.12467

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.12489

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
See 12 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GammaExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. [2023]
Are We Doing More Than We Know? Possible Mechanisms of Response to Music Therapy. [2020]
[Music therapy in Alzheimer's disease: is an evidence-based approach possible?]. [2006]
Integrating music-based interventions with Gamma-frequency stimulation: Implications for healthy ageing. [2023]
Alzheimer's disease: rhythm, timing and music as therapy. [2022]
Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset. [2022]
A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. [2022]
Music therapy in neurological rehabilitation settings. [2017]
Music therapy with Alzheimer's patients and their family caregivers: a pilot project. [2022]
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