Back to resultsEffects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI
Primary Purpose
Regional Cerebral Blood Flow, Mild Cognitive Impairment, Cognitive Function
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Photobiomodulation device
Sponsored by
About this trial
This is an interventional treatment trial for Regional Cerebral Blood Flow focused on measuring Photobiomodulation
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).
Sites / Locations
- Pusan national university Yangsan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PBM(Photobiomodulation)
Arm 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.
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04721093
First Posted
January 14, 2021
Last Updated
January 20, 2021
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04721093
Brief Title
Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Cerebral Blood Flow, Mild Cognitive Impairment, Cognitive Function
Keywords
Photobiomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with Mild Cognitive Impairment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBM(Photobiomodulation)
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation device
Other Intervention Name(s)
Low level light theraphy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Korean Version of Montreal Cognitive Assessment(MoCA) score change
Description
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).
Time Frame
Baseline and week 8
Title
Single photon emission computed tomography(SPECT) z-score change
Description
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).
Time Frame
Baseline and week 8
Title
The verbal learning test(VLT) score change
Description
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).
Time Frame
Baseline and week 8
Title
The trail making test(TMT) score change
Description
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).
Time Frame
Baseline and week 8
Title
Boston naming test(BNT) score change
Description
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).
Time Frame
Baseline and week 8
Title
Rey complex figure test(RCFT)-'copy' score change
Description
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).
Time Frame
Baseline and week 8
Title
Rey complex figure test(RCFT)-'Immediate Recall' score change
Description
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).
Time Frame
Baseline and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-il Shin, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pusan national university Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan
ZIP/Postal Code
50610
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI
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