Gamma-Music Therapy for Alzheimer's Disease
(NUGammaMBI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northeastern University
Must be taking: Cholinesterase inhibitors, Memantine
Disqualifiers: Stroke, Psychiatric disorders, Substance abuse, others
Trial Summary
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.
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.
12345Is 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.
14567How 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.
14589Eligibility Criteria
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
+12 more
Exclusion Criteria
Participants who fail audiometric screening
Participants with contraindications to MRI scanning
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GammaExperimental Treatment1 Intervention
8-week music-based intervention with gamma lights
Group II: ControlPlacebo Group1 Intervention
8-week music-based intervention with control lights
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northeastern UniversityBoston, MA
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Who Is Running the Clinical Trial?
Northeastern UniversityLead Sponsor
References
Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. [2023]Dementia prevalence is increasing globally, and symptom management and treatment strategies require further investigation. Music-based interventions have demonstrated some efficacy with respect to quality of life and symptom reduction, though limited with respect to cognition. This study reports on three case studies where the use of gamma stimulation over one year contributed to maintenance of cognition and increases in mood for participants with Alzheimer's disease or mild cognitive impairment. Auditory stimulation with isochronous sound at 40 Hz was delivered to participants via a commercially available vibroacoustic chair device five times per week for 30 min with assistance from caregivers. Further research is needed to assess the integration of this therapy in the overall care for persons with dementia.
Are We Doing More Than We Know? Possible Mechanisms of Response to Music Therapy. [2020]Due to advances in medical knowledge the population of older adults struggling with issues of aging like Alzheimer's disease (AD), Parkinson's disease (PD), and stroke is growing. There is a need for therapeutic interventions to provide adaptive strategies to sustain quality of life, decrease neurologic impairment, and maintain or slow cognitive decline and function due to degenerative neurologic diseases. Musical interventions with adults with cognitive impairments have received increased attention over the past few years, such as the value of personalized music listening in the iPod project for AD (1); music as a tool to decrease agitation and anxiety in dementia (2); and music to aid in episodic memory (3); Rhythmic Auditory Stimulation as rehabilitation for PD (4); and recently the potential of 40 Hz sensory brain stimulation with AD and PD (5, 6). These approaches indicate the expanding scope and efficacy of music therapy and the potential mechanisms involved. This paper explicates a four-level model of mechanisms of music response (7, 8) that may help understand current music therapy approaches and treatments and help focus future research. Each level will be illustrated with research and suggestions for research directions.
[Music therapy in Alzheimer's disease: is an evidence-based approach possible?]. [2006]The application of music therapy to Alzheimer's patients is relatively recent. The studies available in literature show that music therapy has a positive effect either on mood or cognition. However, the generalization of data is difficult because these researches have lacked methodological design rigour. Based on the application of this rehabilitative technique in our Alzheimer Unit in Brescia and on the recent researches of music neuroanatomy, this work tries to identify which processes are involved in the therapeutic effect of music therapy. Despite the perceived effect on mood and socialisation abilities, cultural and methodological problems hinder to demonstrate the efficacy of music therapy. Information about neurophysiological and neurochemical correlates of music therapy are so poor that the use of this technique is often based on the assumption that the supposed positive effect of music is enough to justify its application. The methodological problem is related to the evaluation of outcomes. The fact that those studies which investigated the effects of music therapy were characterized by less specific indicators (cognition, behavior) and by less standardized instruments made difficult to generalize and quantify the results. The aim of the study is to organize the present knowledge with a systematic approach so that further researches lead to base the application of music therapy on evidence instead of on singular clinical finding.
Integrating music-based interventions with Gamma-frequency stimulation: Implications for healthy ageing. [2023]In recent years, music-based interventions (MBIs) have risen in popularity as a non-invasive, sustainable form of care for treating dementia-related disorders, such as Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD). Despite their clinical potential, evidence regarding the efficacy of MBIs on patient outcomes is mixed. Recently, a line of related research has begun to investigate the clinical impact of non-invasive Gamma-frequency (e.g., 40 Hz) sensory stimulation on dementia. Current work, using non-human-animal models of AD, suggests that non-invasive Gamma-frequency stimulation can remediate multiple pathophysiologies of dementia at the molecular, cellular and neural-systems scales, and, importantly, improve cognitive functioning. These findings suggest that the efficacy of MBIs could, in theory, be enhanced by incorporating Gamma-frequency stimulation into current MBI protocols. In the current review, we propose a novel clinical framework for non-invasively treating dementia-related disorders that combines previous MBIs with current approaches employing Gamma-frequency sensory stimulation. We theorize that combining MBIs with Gamma-frequency stimulation could increase the therapeutic power of MBIs by simultaneously targeting multiple biomarkers of dementia, restoring neural activity that underlies learning and memory (e.g., Gamma-frequency neural activity, Theta-Gamma coupling), and actively engaging auditory and reward networks in the brain to promote behavioural change.
Alzheimer's disease: rhythm, timing and music as therapy. [2022]Active music-making provides a form of therapy for the Alzheimer's patient which may stimulate cognitive activities such that areas subject to progressive failure are maintained. Anecdotal evidence suggests that quality of life of Alzheimer's patients is significantly improved with music therapy, accompanied by the overall social benefits of acceptance and sense of belonging gained by communicating with others. Music therapy, when based on clear treatment objectives can reduce the individual prescription of tranquilizing medication, reduce the use of hypnotics and help overall goals of rehabilitation. Mood improvement and self-expression, the stimulation of speech and organisation of mental processes; and sensory stimulation and motor integration are promoted. Given that the rate of deterioration in Alzheimer's disease is not predictable, a series of single case experimental designs would generate valuable empirical data concerning treatment outcome and promote basic research into the timing functions required for the co-ordination of cognition, physiology, motor ability and the integrity of behaviour.
Non-invasive auditory brain stimulation for gamma-band entrainment in dementia patients: An EEG dataset. [2022]Gamma entrainment has been shown to enhance beta amyloid (Aβ) uptake in mouse models of Alzheimer's disease (AD) as well as improve cognitive symptoms of dementia in both humans and mice. Similar improvements have been reported for both invasive and non-invasive brain stimulation in the gamma oscillatory band, with 40 Hz auditory and visual sensory stimulants employed in non-invasive approaches. Non-invasive stimulation techniques possess the clear advantage of not requiring surgical procedures and can hence be applicable to a wider set of patients. The dataset introduced here was acquired with the aim of examining the network-level mechanisms governing the production of the brain's oscillatory activity during non-invasive auditory gamma-band stimulation, and thereby helping to explain the reported therapeutic effects of entrainment in AD patients. Thirteen elderly participants with memory complaints whose conditions were diagnosed as normal aging (non-AD) or mild AD based on the standard criteria for the diagnosis of AD including the mini-mental state exam (MMSE) took part in data collection in which EEG signals were recorded during auditory stimulation of the brain. The data collection session consisted of an initial one-minute rest followed by an alternating set of six stimulation trials interleaved with five rest trials. During each stimulation trial, an auditory stimulant in the form of a 40 Hz chirp was presented to the participant. The collected data from all participants were preprocessed following the full pipeline of Makoto with the use of EEGLAB and posted as a dataset named: Auditory Gamma Entrainment at OpenNeuro repository. The data record for each participant includes the EEG signal represented in standard BIDS format for one-minute rest followed by the auditory task data. A copy of the source EEG data is also provided in .txt format. The dataset can be used to study the characteristics of brain oscillations during entrainment, as well as for studies on auditory perception, analysis of resting state potentials in dementia patients, comparison of auditory evoked potentials with resting state potentials, ERP, ERSP, and SSAVP analysis of auditory response in dementia patients, time series analysis of the stimulation and rest trials, and brain connectivity analysis in dementia patients.
A feasibility trial of gamma sensory flicker for patients with prodromal Alzheimer's disease. [2022]We and collaborators discovered that flickering lights and sound at gamma frequency (40 Hz) reduce Alzheimer's disease (AD) pathology and alter immune cells and signaling in mice. To determine the feasibility of this intervention in humans we tested the safety, tolerability, and daily adherence to extended audiovisual gamma flicker stimulation.
Music therapy in neurological rehabilitation settings. [2017]The neurologic music therapy is a new scope of music therapy. Its techniques deal with dysfunctions resulting from diseases of the human nervous system. Music can be used as an alternative modality to access functions unavailable through non-musical stimulus. Processes in the brain activated by the influence of music can be generalized and transferred to non-musical functions. Therefore, in clinical practice, the translation of non-musical therapeutic exercises into analogous, isomorphic musical exercises is performed. They make use of the executive peculiarity of musical instruments and musical structures to prime, cue and coordinate movements. Among musical components, a repetitive rhythm plays a significant role. It regulates physiologic and behavioural functions through the mechanism of entrainment (synchronization of biological rhythms with musical rhythm based on acoustic resonance). It is especially relevant for patients with a deficient internal timing system in the brain. Additionally, regular rhythmic patterns facilitate memory encoding and decoding of non-musical information hence music is an efficient mnemonic tool. The music as a hierarchical, compound language of time, with its unique ability to access affective/motivational systems in the brain, provides time structures enhancing perception processes, mainly in the range of cognition, language and motor learning. It allows for emotional expression and improvement of the motivation for rehabilitation activities. The new technologies of rhythmic sensory stimulation (i.e. Binaural Beat Stimulation) or rhythmic music in combination with rhythmic light therapy appear. This multimodal forms of stimulation are used in the treatment of stroke, brain injury, dementia and other cognitive deficits. Clinical outcome studies provide evidence of the significant superiority of rehabilitation with music over the one without music.
Music therapy with Alzheimer's patients and their family caregivers: a pilot project. [2022]The purpose of this paper is to present the results of a pilot project sponsored by a private foundation in Spain ("Fundació la Caixa"), in order to demonstrate some of the applications of music therapy, and to measure more systematically some of its effects on people with a probable diagnosis of Alzheimer's Disease and Related Disorders (ADRD) in early-moderate stages of the disease, and their family caregivers. Subjects for this project were 14 patients (5 women and 9 men) with a probable diagnosis of Alzheimer's disease, and 14 family caregivers (9 women and 5 men) from a rural area outside of Barcelona. Their age range was 70 to 80 years. Prior to the beginning of the project, a neuropsychologist specialized in gerontology administered a series of standardized tests to the participants. These same tests were administered again 2 days before the end of the project and 2 months later for follow-up purposes. The results of the satisfaction questionnaire showed that the caregivers perceived an improvement in the social and emotional areas of their patients, and statistical tests showed significant differences between pre and posttest scores in the following tests: (a) Dementia Scale (X2 = 12.29, p = .002), (b) NPI (X2 = 17.72, p = .001), (c) the Cohen-Mansfield agitation scale (X2 = 11.45, p = .003), (d) Burden Interview (X2 = 9.19, p = .01), (e) Memory and Behavior Problems Checklist (frequency subscale) (X2 = 11.09, p = .004), (f) STAI-S (X2 = 14.72, p = .001), and (g) Beck's Depression Inventory (X2 = 9.38, p = .009). These results and their implications are discussed extensively.