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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 55 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04366258
The ClinicalTrials.gov registry entry for NCT04366258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT04366258 reports 0 study locations.
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.
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