Multimodal Musical Stimulation for Healthy Neurocognitive Aging

NCT ID: NCT06229093

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-11

Study Completion Date

2027-12-31

Brief Summary

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This is a Stage I randomized, sham-controlled trial on the effects of multimodal musical stimulation on working memory in aging. Neurologically healthy older and younger adults will be tested on working memory and electroencephalography in the first randomized controlled trial of music as a form of brain stimulation, with multimodal musical stimulation and control stimulation conditions. Results will test the causal role of oscillatory mechanisms of the brain on cognition, and will lay the groundwork to the first musical, neurophysiologically targeted, brain-stimulation device for reversing cognitive decline in aging.

Detailed Description

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Music contains amplitude and frequency modulations, rapid changes in acoustic signals that convey meaningful information to the listener. The human brain's ability to receive and interpret meaning from these signals is implemented by networks of neural oscillations: firing patterns of groups of neurons that track the music with rhythmic activity. Neural oscillations in different frequency bands subserve attention and memory, as well as perception and comprehension; they develop over the lifespan and are reduced in aging, especially in dementia. Being able to understand and causally control neural oscillations will have crucial implications for healthy neurocognitive aging. Since music naturally stimulates the brain with its rhythmic content over time, music may be used as a sustainable, naturalistic form of brain stimulation to induce oscillatory in neuronal populations. Furthermore, by inserting gamma-band energy as sensory stimulation during music listening, gamma-band activity may be increased in the brain in a way that is frequency-tuned to the brain's intrinsic network dynamics, thus replacing the decreased neural oscillations that are reduced in aging, and improving memory and cognition in older adults. The hypothesis is that gamma-band modulations inserted in lights, when coupled with music listening, can improve memory in older adults by frequency-tuning to intrinsic individual brain network dynamics. Results will test the causal role of oscillatory mechanisms of the brain on cognition. If successful, this trial will lay the groundwork to the first musical, neurophysiologically targeted, brain-stimulation device for reversing cognitive decline in aging.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
The assignment of older adults to OA and OAg will be randomized. The within-subjects factor of stimulation modality includes 2 levels, to be administered in counterbalanced order: Visual (V, i.e., lights-only) and Audiovisual (AV, i.e., music-plus-lights). Each subject will be aware that they are receiving V and AV stimulation, and thus infer that we are comparing these two forms of stimulation and therefore assessing the effects of music. However, and important to the design of this study, all subjects will be blinded with respect to their group assignment; i.e., they will not know, until post-study debriefing, about the other arms of the study, and that the gamma-band stimulation is an active ingredient of the intervention.

Study Groups

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Older Adults (OA)

The assignment of older adults to OA and OAg will be randomized. The within-subjects factor of stimulation modality includes 2 levels, to be administered in counterbalanced order: Visual (V, i.e., lights-only) and Audiovisual (AV, i.e., music-plus-lights). Each subject will be aware that they are receiving V and AV stimulation, and thus infer that we are comparing these two forms of stimulation and therefore assessing the effects of music. However, and important to the design of this study, all subjects will be blinded with respect to their group assignment; i.e., they will not know, until post-study debriefing, about the other arms of the study, and that the gamma-band stimulation is an active ingredient of the intervention.

Group Type SHAM_COMPARATOR

Synchrony

Intervention Type DEVICE

For the OA group, the lights will be tuned to delta-band frequencies (1-4 Hz) in the music, which corresponds to the beat-level frequency in most music. Thus, the lights automatically adapt to the rhythm of the music, pulsing on the beat and changing color on strong beats.

Older Adults Gamma (OAg)

The assignment of older adults to OA and OAg will be randomized. The within-subjects factor of stimulation modality includes 2 levels, to be administered in counterbalanced order: Visual (V, i.e., lights-only) and Audiovisual (AV, i.e., music-plus-lights). Each subject will be aware that they are receiving V and AV stimulation, and thus infer that we are comparing these two forms of stimulation and therefore assessing the effects of music. However, and important to the design of this study, all subjects will be blinded with respect to their group assignment; i.e., they will not know, until post-study debriefing, about the other arms of the study, and that the gamma-band stimulation is an active ingredient of the intervention.

Group Type EXPERIMENTAL

Gamma

Intervention Type DEVICE

For the OAg group, the visual component of multimodal stimulation will have the same properties as for the other group, except it will also be additionally amplitude-modulated in the gamma-band (30-60 Hz) range, resulting in a detectable flicker over-and-above the beat-level modulation.

Interventions

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Gamma

For the OAg group, the visual component of multimodal stimulation will have the same properties as for the other group, except it will also be additionally amplitude-modulated in the gamma-band (30-60 Hz) range, resulting in a detectable flicker over-and-above the beat-level modulation.

Intervention Type DEVICE

Synchrony

For the OA group, the lights will be tuned to delta-band frequencies (1-4 Hz) in the music, which corresponds to the beat-level frequency in most music. Thus, the lights automatically adapt to the rhythm of the music, pulsing on the beat and changing color on strong beats.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* normal or corrected-to-normal vision
* no more than mild hearing loss
* no recent history of neurological or psychiatric disorders, including mood disorders or use of medications that may affect cognition or responsiveness to music.

Exclusion Criteria

* moderate or severe hearing loss (40+ dB)
* visual impairment (including color blindness) that cannot be corrected with glasses or contacts
* recently changed dosage of cholinesterase inhibitors or psychotropic medication
* recent history of psychotic or schizophrenic episodes
* major neurologic diagnosis or other condition that might impair cognition or confound assessments (dementia, ADRD; Parkinson's disease, stroke, brain injury, epilepsy, or recent cardiovascular or neurovascular event)
* recent history of serious physical trauma or diagnosis of serious chronic health condition requiring medical treatment and monitoring .
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Psyche Loui

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Psyche Loui, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Corinna Parrish

Role: CONTACT

781-474-3141

Facility Contacts

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Corinna Parrish

Role: primary

781-474-3141

Other Identifiers

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NortheasternMINDLabMultimodal

Identifier Type: -

Identifier Source: org_study_id

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