NCT04721093

Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI

Effects and Safety Evaluation of Changes in Cognitive Function of Photobiomodulation Treatment for Patients With Mild Cognitive Impairment (MCI): Single-institutional Prospective Clinical Trial, Single Group, Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This pilot study has two goals. The first is to see if the cognitive improves when VA and CA are stimulated in MCI patients, and the second is to do an explanatory data analysis to see if that improves cognitive in relation to the rCBF improvement.

Detailed description

After being informed about the study and potential risks, all patients giving written informed codsent sill undergo a 1 day screening period to determine eligibility for study entry. Subjects who pass the screening test will receive a registration number within 7 days and proceed with the pre-intervention test as follows.

Conditions

• Regional Cerebral Blood Flow
• Mild Cognitive Impairment
• Cognitive Function

Interventions

Type	Name	Description
DEVICE	Photobiomodulation device	In this study, PBM was applied using a machine made to be attached to the subject in the form of a probe. In this clinical trial, a low-intensity irradiation device (Color-DNA-WSF U) from Color seven was used to deliver visible light (610nm± 10nm wavelength, 3.0mW/㎠±20%) irradiation. PBM was applied 5 times a week for 8 weeks, 30 minutes per session.

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-04-30
• Completion: 2020-06-30
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: South Korea