NCT07318038

Brief Summary

In this within-subjects, crossover study, participants will undergo Electroencephalogram (EEG) recordings before, during, and after each of three 1-hour sessions. All participants will experience all three conditions: (1) dual-frequency visual (10 and 40 Hz), (2) single-frequency visual (40 Hz), and (3) non-rhythmic stimulation. EEG spectral power and amplitude coupling will be analyzed to determine whether stimulation-induced increases in alpha-gamma neural synchrony translate to improvements in cognitive performance.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Dec 2025Jun 2026

Study Start

First participant enrolled

December 8, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • EEG-based neural synchrony

    Change in spectral power and amplitude in the alpha and gamma EEG bands. Increase in power and amplitude is indicative of increases in neural synchrony.

    5 minute EEG recording will be done at start, middle and end of each one-hour session, each session separated by one week

Secondary Outcomes (1)

  • Digit Span Task

    Completed at start and end of each one-hour session, each session will be separated by one week

Study Arms (3)

Dual frequency flickering light

EXPERIMENTAL

Light flickering with 10 Hz + 40 Hz visual stimulation

Device: Flickering Light

Single frequency flickering light

EXPERIMENTAL

Light flickering with 10 Hz visual stimulation

Device: Flickering Light

non-rhythmic flickering light

PLACEBO COMPARATOR

Light flickering with random visual stimulation

Device: Flickering Light

Interventions

Red Flickering Light programed to three different visual stimulations

Dual frequency flickering lightSingle frequency flickering lightnon-rhythmic flickering light

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of Mild Cognitive Impairment with a Montreal Cognitive Assessment score between 18 and 25

You may not qualify if:

  • History of epilepsy or photosensitivity
  • Blindness or other obstructive vision conditions
  • retinal diseases
  • presence of another brain disease accounting for their cognitive status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Mariana Figueiro, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

As the primary outcome measure of this study is EEG recordings, individual results will not be shared.

Locations