- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07318038
The Use of Rhythmic Light Therapy in Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara Plitnick
- Phone Number: 518-242-4603
- Email: barbara.plitnick@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Barbara Plitnick
- Phone Number: 518-242-4603
- Email: barbara.plitnick@mountsinai.org
-
Principal Investigator:
- Mariana Figueiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- History of Mild Cognitive Impairment with a Montreal Cognitive Assessment score between 18 and 25
Exclusion Criteria:
- History of epilepsy or photosensitivity
- Blindness or other obstructive vision conditions
- retinal diseases
- presence of another brain disease accounting for their cognitive status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual frequency flickering light
Light flickering with 10 Hz + 40 Hz visual stimulation
|
Red Flickering Light programed to three different visual stimulations
|
|
Experimental: Single frequency flickering light
Light flickering with 10 Hz visual stimulation
|
Red Flickering Light programed to three different visual stimulations
|
|
Placebo Comparator: non-rhythmic flickering light
Light flickering with random visual stimulation
|
Red Flickering Light programed to three different visual stimulations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG-based neural synchrony
Time Frame: 5 minute EEG recording will be done at start, middle and end of each one-hour session, each session separated by one week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digit Span Task
Time Frame: Completed at start and end of each one-hour session, each session will be separated by one week
|
Change in cognition will be measured by the Digit Span Task which is a working memory task. Increase in accuracy and response time indicates improved cognitive performance. Digit Span. Memory span is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. Memory span is a common measure of short-term memory. A digit-span task is used to measure working memory's number storage capacity. The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 16 points. Higher score indicates better health outcomes. |
Completed at start and end of each one-hour session, each session will be separated by one week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mariana Figueiro, PhD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-25-01233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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