Regional Cerebral Blood FlowNCT04721093
Effects of Photobiomodulation on Changes in Cognitive Function and rCBF in MCI
A study testing Photobiomodulation device in people with Regional Cerebral Blood Flow and Mild Cognitive Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Regional Cerebral Blood Flow, Mild Cognitive Impairment, Cognitive Function
- What is being tested?
- Photobiomodulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any psychiatric disorders such as schizophrenia that would compromise participation
- Those with central nervous system disease
- Serious cognitive problems(MoCA score 7 or less).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610
About this study
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
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.
Read the 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.
- Being tested
- Photobiomodulation device
- Keywords
- Photobiomodulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation deviceDevice
Also called Low level light theraphy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Photobiomodulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start12 Dec 2019
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Cerebral Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with Mild Cognitive Impairment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
- Investigators
- Yong-il Shin, PhD, Study director, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721093
- Sponsor's protocol ID
- 03-2018-006
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04721093
- Acronym / sponsor ID
- 03-2018-006
- Keywords
- Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with Mild Cognitive Impairment
| Arm | Type | Receives |
|---|---|---|
| PBM(Photobiomodulation) | Experimental | Device: Photobiomodulation deviceSubjects 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Any psychiatric disorders such as schizophrenia that would compromise participation
- Those with central nervous system disease
- Serious cognitive problems(MoCA score 7 or less).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation deviceAlso: Low level light theraphyIn 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. | Device | PBM(Photobiomodulation) |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Regional Cerebral Blood Flow
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Not yet recruitingObservational study
Inflammatory Markers and Prognosis After Cerebral Thrombectomy in Large Vessel Occlusion
Acute Ischemic Stroke, Large Vessel Occlusion
RecruitingObservational study
Predictive Value of ONSD and NIRS for PDPH
Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
RecruitingObservational study
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
Organ Transplant
Not yet recruitingPhase 3
Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-il Shin, PhD study director
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation device in people with Regional Cerebral Blood Flow and Mild Cognitive Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean Version of Montreal Cognitive Assessment(MoCA) score change (time frame: Baseline and week 8). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.