- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229093
Multimodal Musical Stimulation for Healthy Neurocognitive Aging (Multimodal)
July 8, 2025 updated by: Psyche Loui, Northeastern University
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Corinna Parrish
- Phone Number: 781-474-3141
- Email: c.parrish@northeastern.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Principal Investigator:
- Psyche Loui, PhD
-
Contact:
- Corinna Parrish
- Phone Number: 781-474-3141
- Email: c.parrish@northeastern.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG
Time Frame: 8 weeks
|
Delta, theta, and gamma frequencies
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working Memory
Time Frame: 8 weeks
|
delayed-matched-to-sample task
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Psyche Loui, PhD, Northeastern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 29, 2024
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
July 8, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NortheasternMINDLabMultimodal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Radboud University Medical CenterTerminated
-
Northwestern UniversityPotocsnak Human Longevity LabRecruitingAging | Aging Well | Aging, Biological | Aging, HealthyUnited States
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
Arizona State UniversityActive, not recruiting
-
San Diego State UniversityCompleted
Clinical Trials on Synchrony
-
Med-El CorporationCompletedHearing Loss, SensorineuralCanada, United States
-
United Christian HospitalCompletedChronic Obstructive Pulmonary Disease | Hypercapnic Respiratory FailureHong Kong
-
Med-El CorporationCompletedHearing Loss, SensorineuralUnited States
-
Philips RespironicsUniversity of Pittsburgh Medical CenterTerminatedChronic Obstructive Pulmonary DiseaseUnited States
-
Appalachian State UniversityActive, not recruitingExecutive Function (Cognition) | Preschool ChildUnited States
-
University Hospital, MontpellierTerminated
-
University of North Carolina, Chapel HillMed-El CorporationCompletedHearing Loss, UnilateralUnited States
-
Philips RespironicsCompletedChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
Allina Health SystemRecruitingHeart Failure, SystolicUnited States
-
Region SkaneEnrolling by invitationCancer of Lung | Cancer of Prostate | Lung MetastasisSweden