A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits

Yong-il Shin, MD

Status: Unknown

Conditions: Cerebral Blood Flow; Low-level Light Therapy; Mild Cognitive Impairment; Brain Activity

Treatments: Device: Low-level light therapy device

Study type: Interventional

Funder types: Other

Identifiers

NCT03192670

PNUYH-03-2017-003, SMC-2016-1

Details and patient eligibility

About

The primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment.

Full description

Total 168 patients were recruited and randomized to receive either real or sham-LED-T. Real experimental groups were divided into three groups; CA group, VA group, CA+VA dual group. Each group received LED-T (30 min) once a day for 30 days. Each groups LED-T positioned at following locations;

• CA group on the superior border of the thyroid cartilage, and anterior to the sternocleidomastoid muscle based on Korea traditional therapy called Inyoung(ST9)
• VA group on the upper abdomen, spinous process of the 2nd cervical vertebra upper margin based on Korea traditional therapy called CunChu
• CA+VA dual group on the CA position (ST9), and VA position (BL10) The patients were initially evaluated at baseline, immediately, 4wks after intervention.

Study type : Interventional Study Phase : Not provided Study Design : Allocation : Randomized Intervention Model : Parallel Assignment Masking : Single Blind (Investigator) Primary Purpose : Treatment, intervention Condition : Mild cognitive impairment, Health subjects

Intervention :

• Low-level light therapy device (Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter),
• Parameters : Neuroimaging assessement: fMRI, SPECT, Neuropsychological behavioral assessment: SNSB; Seoul Neuropsychological screening battery, K-MoCA, Corsi-block test, K-MBI, K-ADL, GDS, EQ-5D, Neurophysiological assessment: MEP, Motor evoked potential, Gene test(BNDF, ApoE)

Study Arms

• Experimental : Sham control group and real stimulation group.
• In each group, total sessions of the Low-level light therapy (LED-T) was done for intervention was followed after that.
• Subjects received LED-T (30 min) once a day for 30 days.
• The sham control group was kept without LED-T

Enrollment: 168 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects ages older than 55 years old
2. Subjects who has K-MoCA assessment score less than 23
3. Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver

Exclusion criteria

1. Subjects who have K-MMSE less than 19
2. Subjects who have pre-existing and present-existing neurological diseases as CNS lesion
3. Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia
4. Subjects who is estimated as not appropriate for the study by the investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 4 patient groups

Sham control group

Sham Comparator group

Description:

Sham control group received same procedure without LED-T. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)

Treatment:

Device: Low-level light therapy device

CA(Carotid artery)-stimulation group

Experimental group

Description:

In CA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)

Treatment:

Device: Low-level light therapy device

VA(Vertebral artery)-stimulation group

Experimental group

Description:

In VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)

Treatment:

Device: Low-level light therapy device

CA+VA dual stimulation group

Experimental group

Description:

In CA+VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)

Treatment:

Device: Low-level light therapy device