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

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Regional Cerebral Blood Flow; Cognitive Function; Mild Cognitive Impairment

Treatments: Device: Photobiomodulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT04721093

03-2018-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients with mild cognitive impairment(MCI). The MCI was diagnosed based on medical history and neurological examination
• A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion criteria

• Any psychiatric disorders such as schizophrenia that would compromise participation
• Those with central nervous system disease
• Serious cognitive problems(MoCA score 7 or less).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

PBM(Photobiomodulation)

Experimental group

Description:

Subjects applied PBM(Color-DNA-WSF U, Color Seven; 610 nm±10nm wavelength; 3.0 mW/㎠±20%) therapy in the locations of the sternocleidomastoid muscle in the ICA area and the trapezius muscle in VA area. PBM was applied 5 times a week for 8 weeks, 30 minutes per session.

Treatment:

Device: Photobiomodulation device