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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721093
• Other study ID #: 03-2018-006
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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