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

January 20, 2021 updated by: Yong-il Shin, Pusan National University Yangsan Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Yangsan
      • Gyeongsang, Yangsan, Korea, Republic of, 50610
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Other Names:
  • Low level light theraphy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Korean Version of Montreal Cognitive Assessment(MoCA) score change
Time Frame: Baseline and week 8
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
Time Frame: Baseline and week 8
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
Time Frame: Baseline and week 8
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
Time Frame: Baseline and week 8

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
Time Frame: Baseline and week 8
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
Time Frame: Baseline and week 8
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
Time Frame: Baseline and week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University Yangsan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yong-il Shin, PhD, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03-2018-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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