Transcranial photobiomodulation plus cognitive training for memory in aMCI
The Effects of Transcranial Photobiomodulation (t-PBM) on Cognitive Performance and Functional Brain Connectivity in Patients With Mild Cognitive Impairment and the Role of Genetic Factors
This study will see if adding transcranial photobiomodulation (a low‑level light therapy) to cognitive training helps people aged 55 and older with amnestic mild cognitive impairment improve memory and thinking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Uskudar University Academic / other |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT07287527 on ClinicalTrials.gov |
What this trial studies
This randomized, sham‑controlled, pretest‑posttest trial enrolls older adults with amnestic MCI and assigns them to active transcranial photobiomodulation (t‑PBM) plus a standardized cognitive rehabilitation program or to sham t‑PBM with the same training. The intervention is delivered across eight in‑person sessions while participants complete cognitive testing and resting‑state fMRI before the first session and after the final session to measure changes in cognition and default mode network connectivity. Blood is collected for genetic profiling and diet is monitored at baseline and follow‑up to reduce confounding. The design focuses on Group × Time effects to determine whether active t‑PBM produces larger cognitive or connectivity changes than sham.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 or older with a confirmed diagnosis of amnestic mild cognitive impairment who can undergo MRI and attend eight in‑person intervention sessions.
Not a fit: Individuals with other neurological disorders, severe psychiatric illness, or MRI‑incompatible implanted medical devices (for example pacemakers) are unlikely to be eligible and may not receive benefit.
Why it matters
Potential benefit: If effective, the combined t‑PBM and cognitive training approach could improve memory and modify brain network activity, potentially slowing decline associated with Alzheimer's risk.
How similar studies have performed: Small and preliminary human studies have shown some promising cognitive or connectivity changes with t‑PBM, but controlled evidence in aMCI is limited and results remain preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 55 years or older * Diagnosis of amnestic Mild Cognitive Impairment (aMCI) Exclusion Criteria: * Presence of a neurological disorder * Presence of a severe psychiatric disorder * Having a pacemaker or other implanted medical device that is not MRI-compatible
Where this trial is running
Istanbul and 1 other locations
- NPIstanbul Brain Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Uskudar University, Faculty of Medicine — Istnabul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Baris Metin, Prof. Dr. — Uskudar University
- Study coordinator: Shams Farhad, PhD
- Email: shams.farhad@uskudar.edu.tr
- Phone: +905528566917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.