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NCT04366258 · ClinicalTrials.gov registry record · NA
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT04366258: Completed NA study, sponsored by NYU Langone Health.
NCT04366258 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04366258, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eligible participants will undergo four sessions of t-PBM during fMRI so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of dose administration will be randomized and t-PBM will be administered with the LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0).
Primary Outcome
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans.
Interventions
- DEVICE Sham
- DEVICE Transcranial Photobiomodulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-06-24 |
| Phase | NA |
What the finished NCT04366258 record still lists
NCT04366258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT04366258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04366258 about?
NCT04366258 is a clinical study titled "Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression". This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eli...
What is the current status of trial NCT04366258?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2020-08-01. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT04366258?
The interventions under investigation include: Sham (DEVICE), Transcranial Photobiomodulator (DEVICE).
Who is sponsoring clinical trial NCT04366258?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04366258's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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