The Effect of Laser Acupuncture in Different Meridians on the Autonomic Nervous System and Its Brain Mechanisms

NCT05458713 | Completed

• 1 other identifier: MOST 111-2320-B-039-031-MY2
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional Chinese acupuncture has a history of several thousand years. The World Health Organization has published guidelines describing the efficacy of acupuncture in the cure or relief of 64 different symptoms and conditions as one of the most representative intangible cultural heritage of humanity. In recent years, the applications of laser acupuncture, or so-called low-level laser therapy which are belong to the domain of photobiomodulation therapy, become widespread. Laser acupuncture is not only applicate to stimuli specific areas in need, but also one of non-invasive intervention technic with hurtles intervention, no hematoma, bleeding or swelling unpleasant feeling after intervention, which could be more accepted by children, weakness people, and patients who afraid of acupuncture. However, the underlined mechanisms and the neural pathway of laser acupuncture are still obscure. The inconsistent results from previous studies have been reported that laser acupuncture stimulation on the Neiguan (PC 6), the acupoint of Pericardium meridian, could affect the autonomic nerve system in terms of heart rate, blood pressure, activities of sympathetic and/or parasympathetic nerves. The results of previous studies on the changes of autonomic nervous system (ANS) caused by laser acupuncture on Neiguan (PC6), an acupoint of the pericardium meridian, have been inconsistent. Our preliminary results show that laser acupuncture on PC6 seems to have a biphasic dosage effect on the ANS changes. However, little is known about the possible central mechanisms underpinned these ANS changes. In addition, whether laser acupuncture on different meridians will also induce a biphasic dosage effect on the ANS is still unknown. Therefore, the main purposes of this project are: 1) to explore the changes of ANS and associated brain networks by applying laser acupuncture with on PC6 different intensities; and 2) to explore whether applying laser acupuncture on different meridians will have different ANS and related brain network responses. In this two-year, single-blind, parallel experiment design project, the recruited healthy subjects will randomly assign to the group with high energy density, low energy density, or no energy of laser acupuncture on PC6 (in first year) or on Shugu (in second year), which is an acupoint of the bladder meridian (BL65). Via a non-invasive wearable photoplethysmography, the peripheral pulse rate variability will be calculated as the index of ANS changes. In addition, the resting-state functional MRI scans will be performed before and after laser acupuncture to explore the immediate changes in the brain networks that may regulates the activity of ANS. The investigators hope that through the application of modern scientific methods to probe the meridian phenomenon in Chinese medicine, The investigators can further understand the neurological mechanisms of the meridian and provide a new insight for the traditional meridian theory of Chinese medicine.

Conditions

Laser Acupuncture; Meridian; Brain Mechanism; Heart Rate Variability

Keywords

pericardium meridian; laser acupuncture; pulse rate variability; Resting-state functional magnetic resonance imaging; bladder meridian

Outcome Measures

Primary Outcomes (1)

• Functional connectivity in brain

  The changes of functional connectivity with laser acupuncture intervention

  500 seconds before and 30 seconds after laser acupuncture intervention

Secondary Outcomes (1)

• Heart rate variability (HRV)

  500 seconds before and 30 seconds after laser acupuncture intervention

Study Arms (6)

PC6 High Energy group

EXPERIMENTAL

The participants of this group will be irradiated with a 4mm probe for 60 seconds with an output power of 100mW on PC6 (acupoint Neiguan).

Device: Laser acupuncture

PC6 Low Energy group

EXPERIMENTAL

The participants of this group will be irradiated with a 4mm probe for 20 seconds with an output power of 100mW on PC6 (acupoint Neiguan).

Device: Laser acupuncture

PC6 Placebo group

PLACEBO COMPARATOR

The participants of this group will be irradiated with a 4mm probe for 0 seconds with an output power of 100mW on PC6 (acupoint Neiguan).

Device: Laser acupuncture

BL65 High Energy group

ACTIVE COMPARATOR

The participants of this group will be irradiated with a 4mm probe for 60 seconds with an output power of 100mW on BL65 (acupoint Shugu).

Device: Laser acupuncture

BL65 Low Energy group

ACTIVE COMPARATOR

The participants of this group will be irradiated with a 4mm probe for 20 seconds with an output power of 100mW on BL65 (acupoint Shugu).

Device: Laser acupuncture

BL65 Sham group

SHAM COMPARATOR

The participants of this group will be irradiated with a 4mm probe for 0 seconds with an output power of 100mW on BL65 (acupoint Shugu).

Device: Laser acupuncture

Interventions

Laser acupuncture DEVICE

Irradiate acupoints with low power laser

BL65 High Energy group; BL65 Low Energy group; BL65 Sham group; PC6 High Energy group; PC6 Low Energy group; PC6 Placebo group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages of 20 and 55.
• Body Mass Index (BMI) should fall between 18.5 and 24 kg/m2.
• Voluntarily sign the subject's consent form reviewed and approved by the human trial committee, indicating voluntary participation in the research.

You may not qualify if:

• Those diagnosed with chronic diseases such as coronary artery disease, diabetes, hypertension, hyperlipidemia, cancer, etc.
• With the brain diseases, such as epilepsy, stroke, Parkinson's disease, dementia, brain tumor, traumatic brain injury, head trauma or brain surgery, etc.
• The positive result for wrist Tinel sign, or who have experienced neurological symptoms such as median nerve compression recently and during the experiment.
• Patients with mental disorders, such as major depression, bipolar disorder, generalized anxiety disorder, claustrophobia, schizophrenia, etc.
• Cannot follow the instructions to perform the experiment due to hyperactivity and agitation.
• Taken neuropsychiatric drugs (such as sleeping pills, anti-anxiety drugs) or pain relievers and other drugs that affect nerve activity in the past three months.
• Pregnant, plan to pregnant, or menopausal women.
• Having metal implants in the body, or equipping with a pacemaker.
• With scars or open wounds at the acupoints selection site, or the skin condition at the site may affect the selection of acupoints or laser acupuncture.

Sponsors & Collaborators

• China Medical University, Taiwan: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 14, 2022
• Study Start: November 13, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)