Multimodal Musical Stimulation for Healthy Neurocognitive Aging

NCT06229093 | Recruiting DMC

• 1 other identifier: NortheasternMINDLabMultimodal
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Music

Outcome Measures

Primary Outcomes (1)

• EEG

  Delta, theta, and gamma frequencies

  8 weeks

Secondary Outcomes (1)

• Working Memory

  8 weeks

Study Arms (2)

Older Adults (OA)

SHAM COMPARATOR

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.

Device: Synchrony

Older Adults Gamma (OAg)

EXPERIMENTAL

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.

Device: Gamma

Interventions

Gamma 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.

Older Adults Gamma (OAg)

Synchrony 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 (OA)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Electroencephalography Phase Synchronization

Intervention Hierarchy (Ancestors)

Electroencephalography; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Electrophysiological Phenomena; Physiological Phenomena

Study Officials

• Psyche Loui, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinna Parrish

CONTACT

781-474-3141; c.parrish@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 29, 2024
• Study Start: December 11, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)