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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06229093
Other study ID # NortheasternMINDLabMultimodal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2022
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Northeastern University
Contact Psyche Loui, PhD
Phone 6173736588
Email p.loui@northeastern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
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.
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.

Locations

Country Name City State
United States Northeastern University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG Delta, theta, and gamma frequencies 8 weeks
Secondary Working Memory delayed-matched-to-sample task 8 weeks
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