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

NCT ID: NCT04721093

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-12
• Study Completion Date: 2020-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PBM(Photobiomodulation)

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.

Group Type: EXPERIMENTAL

Photobiomodulation device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Low level light theraphy

Eligibility Criteria

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).

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Head of Rehabilitation Medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-il Shin, PhD

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Countries

South Korea

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

03-2018-006

Identifier Type: -

Identifier Source: org_study_id