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

NCT04721093 | Completed

• 1 other identifier: 03-2018-006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Cerebral Blood Flow; Mild Cognitive Impairment; Cognitive Function

Keywords

Photobiomodulation

Outcome Measures

Primary Outcomes (7)

• Korean Version of Montreal Cognitive Assessment(MoCA) score change

  The MoCA is a validated, instrument assessing overall cognitive function in patients with mild cognitive impairment. Possible scores range from 0 to 30(Higher numbers indicate better cognitive function). Change=(week 8 score-baseline score).

  Baseline and week 8

• Single photon emission computed tomography(SPECT) z-score change

  The SPECT is a validated, instrument assessing regional Cerebral Blood Flow(rCBF). Possible scores range from -6.5 to 6.5. The score indicates how far the data value is from the means for each region from the normal database. Change=(week 8 score-baseline score).

  Baseline and week 8

• The verbal learning test(VLT) score change

  The VLT is a validated, instrument assessing memory domain. The VLT is a task in which the examiner reads 12 words and the subject is immediately asked to remember as many words as possible. Possible scores range from 0 to 12(Higher numbers indicate better). Change=(week 8 score-baseline score).

  Baseline and week 8

• The trail making test(TMT) score change

  The TMT is a validated, instrument assessing frontal/executive functions domain, requires the subject to draw a line that alternates between numbers and days of the week in a consecutive manner. The score is calculated by subtracting the number of errors from the total time it took to complete the test. And the score is converted to %ile(0 to 100) based on the normal database and changed(Higher numbers indicate better). Change=(week 8 score-baseline score).

  Baseline and week 8

• Boston naming test(BNT) score change

  The BNT is a validated, instrument assessing visual confrontation naming. BNT assesses the naming ability using 60 black and white images that are organized. The subject is asked to name what is depicted in the image. Possible scores range from 0 to 60(Higher numbers indicate better). Change=(week 8 score-baseline score).

  Baseline and week 8

• Rey complex figure test(RCFT)-'copy' score change

  The RCFT 'copy' is a validated, instrument assessing visuo-constructive abilities. The RCFT 'copy' requires the subject to observe and replicate an image. The score is scored as 0, 0.5, 1 or 2 for each of the 18 factors. Point 2 is when the shape and position of the element is accurately drawn, point 1 is when one of the shape or position is correct. Point 0.5 is when both the shape and position are incorrect, but the examinee can determine what the subject was trying to draw, and point 0 is the case when the shape and position difference are both inadequate, and when the element is not drawn. The total score is the sum of the scores scored for each of the 18 elements; It is possible scores range from 0 to 36(Higher numbers indicate better). Change=(week 8 score-baseline score).

  Baseline and week 8

• Rey complex figure test(RCFT)-'Immediate Recall' score change

  The RCFT 'immediate recall' is a validated, instrument assessing visuo-constructive memory abilities. The RCFT 'immediate recall' requires the subject to flip the page and replicate the image. The score is scored as 0, 0.5, 1 or 2 for each of the 18 factors. Point 2 is when the shape and position of the element is accurately drawn, point 1 is when one of the shape or position is correct. Point 0.5 is when both the shape and position are incorrect, but the examinee can determine what the subject was trying to draw, and point 0 is the case when the shape and position difference are both inadequate, and when the element is not drawn. The total score is the sum of the scores scored for each of the 18 elements; It is possible scores range from 0 to 36(Higher numbers indicate better). Change=(week 8 score-baseline score).

  Baseline and week 8

Study Arms (1)

PBM(Photobiomodulation)

EXPERIMENTAL

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.

Device: Photobiomodulation device

Interventions

Photobiomodulation device 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.

Also known as: Low level light theraphy

PBM(Photobiomodulation)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yong-il Shin, PhD

  Pusan National University Yangsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Medicine, Principal Investigator

Model Details: Patients with Mild Cognitive Impairment

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: December 12, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)