AgingMultimodalNCT06229093
Multimodal Musical Stimulation for Healthy Neurocognitive Aging
A study testing Gamma and Synchrony in people with Aging, run by Northeastern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Gamma and Synchrony
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Corinna Parrish, 781-474-3141, c.parrish@northeastern.edu
Psyche Loui, PhD
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Gamma, Synchrony
- Keywords
- Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaDevice
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.
SynchronyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
Delta, theta, and gamma frequencies
Measured: 8 weeks
Secondary outcomes (1)
Working Memory
delayed-matched-to-sample task
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start11 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Psyche Loui, Northeastern University
- Investigators
- Psyche Loui, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229093
- Sponsor's protocol ID
- NortheasternMINDLabMultimodal
- Acronym
- Multimodal
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2021
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Musical Stimulation for Healthy Neurocognitive Aging
- ClinicalTrials.gov ID
- NCT06229093
- Acronym / sponsor ID
- Multimodal / NortheasternMINDLabMultimodal
- Conditions
- Aging
- Keywords
- Music
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 11 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Adults (OA) | Sham comparator | Device: SynchronyThe 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. |
| Older Adults Gamma (OAg) | Experimental | Device: GammaThe 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaFor 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. | Device | Older Adults Gamma (OAg) |
| SynchronyFor 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. | Device | Older Adults (OA) |
Primary outcome
EEG
Time frame: 8 weeks
Delta, theta, and gamma frequencies
1 secondary outcome
Working Memory
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Psyche Loui, PhD principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma and Synchrony in people with Aging, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinna Parrish (781-474-3141, c.parrish@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.