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Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

Registration number：

ITMCTR2024000296

Date of Last Refreshed on：

2024-08-24

Date of Registration：

2024-08-24

Registration Status：

Retrospective registration

Public title：

Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

English Acronym：

Scientific title：

Observation on the sensitizing effect and mechanism of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis based on "Facial Oral Hegu Shu"

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xu Chen

Study leader：

Chen Jun

Applicant telephone：

15129790108

Study leader's telephone：

15991032768

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1172111760@qq.com

Study leader's E-mail：

584432697@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 5, Weiyang West Road, Qindu District, Xianyang City, Shaanxi Province

Study leader's address：

No. 5, Weiyang West Road, Qindu District, Xianyang City, Shaanxi Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shaanxi University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KJT-SQ2024002

Approved file of Ethical Committee：

View

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/8/15 0:00:00

Contact Name of the ethic committee：

Liu Dan

Contact Address of the ethic committee：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

Contact phone of the ethic committee：

13720452116

Contact email of the ethic committee：

kycxgzb@163.com

Primary sponsor：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Primary sponsor's address：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

Secondary sponsor：

Country：

China

Province：

Shaanxi

City：

Xianyang

Institution
hospital：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Address：

No. 831, Longtaiguan Road, Fengxi New Town, Xixian New District, Xianyang City, Shaanxi Province

Source(s) of funding：

Project funding

Target disease：

peripheral facial nerve palsy

Target disease code：

Study type：

Interventional study

Study design：

Non randomized control

Study phase：

Pilot clinical trial

Objectives of Study：

1. To clarify the synergistic effect of acupuncture at Hegu point on transcranial magnetic stimulation in the treatment of peripheral facial paralysis. 2. Explore the mechanism of "face-oral retraction" through transcranial magnetic stimulation-induced action potential technology. 3. Based on the differences in facial evoked action potentials caused by acupuncture at different acupoints, analyze the differences in the therapeutic effects of different acupoints on peripheral facial paralysis. 4. Provide new treatment options for clinical treatment of peripheral facial paralysis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

This experiment is divided into two parts: a study on healthy subjects and a study on patients with peripheral facial nerve palsy. 1. Inclusion criteria for volunteers in the healthy volunteer group (1) Age 18 to 35 years old, no gender limit; (2) Right-handed; (3) Have good health in the past and can tolerate acupuncture and transcranial magnetic stimulation; (4) No physical abnormalities (such as fever, cough, etc.) during the trial period; (5) Voluntarily participate in this study, fully understand and sign the informed consent form. Cases must all meet the above five criteria to be included. 2. Inclusion criteria for patients with peripheral facial paralysis: (1) Meet the diagnostic standards of traditional Chinese medicine and Western medicine for peripheral facial paralysis; (2) The patient has no contraindications to the transcranial magnetism and acupuncture used; (3) Diagnosed for the first time and unilaterally affected; (4) Age 18 to 65 years old, no gender limit; (5) Voluntarily participate in this study, fully understand and sign the informed consent form. Cases must all meet the above five criteria to be included.

Exclusion criteria：

This experiment is divided into two parts: a study on healthy subjects and a study on patients with peripheral facial nerve palsy. 1. Exclusion criteria for volunteers in the healthy volunteer group (1) Those with a history of craniocerebral trauma or surgery; (2) Patients with neurological diseases such as Parkinson's disease and dementia; (3) Patients with hypertension, diabetes and major heart, liver, kidney and other organ diseases; (4) Those who have pacemakers, stents and other metal objects in their bodies; (5) Those who are afraid or unable to undergo acupuncture, TMS or peripheral nerve electrical stimulation for other reasons; (6) Pregnant person. (7) Patients with severe cerebrovascular, malignant tumors, blood and mental system diseases; (8) Clinical trial participants who also participated in other clinical trials; Note: Patients who meet any of the above conditions should be excluded. 2. 2. Exclusion criteria for peripheral facial paralysis patient group: (1) Those with a history of craniocerebral trauma or surgery; (2) Patients with neurological diseases such as Parkinson's disease and dementia; (3) Patients with hypertension, diabetes and major heart, liver, kidney and other organ diseases; (4) Those who have pacemakers, stents and other metal objects in their bodies; (5) Those who are afraid or unable to undergo acupuncture, TMS or peripheral nerve electrical stimulation for other reasons; (6) Pregnant, perinatal and lactating women; (7) Patients with severe cerebrovascular, malignant tumors, blood and mental system diseases; (8) Clinical trial participants who also participated in other clinical trials; Note: Patients who meet any of the above conditions should be excluded.

Study execute time：

From 2024-08-16

To      2025-08-16

Recruiting time：

From 2024-08-16

To      2025-01-16

Interventions：

30

Group：

Observation group for patients with peripheral facial nerve palsy

Sample size：

Intervention：

Acupuncture and electrical pulse stimulation were performed on the Hegu point of patients with peripheral facial paralysis, and magnetic stimulation evoked potentials were detected before and after the two stimulations.

Intervention code：

30

Group：

healthy volunteer observation group

Sample size：

Intervention：

Acupuncture and electrical pulse stimulation were performed on the Hegu point of healthy volunteers and magnetic stimulation evoked potentials were detected before and after the two stimulations.

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

shaanxi

City：

Xianyang

Institution/hospital：

The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Level of the institution：

Class IIIA

Outcomes：

Outcome：

transcranial magnetic stimulation evoked action potentials

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

House-Brackmann scale score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Others

Note：

This experiment does not require the collection of human specimens

Recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

For healthy volunteers number them according to the expected number of patients to be recruited so that each group is equally assigned to a random number and these number cards are placed in opaque envelopes in shuffled order and then 30 envelopes are mixed and placed in a large Carton each patient will be recruited and the patient himself will draw an envelope from the carton. After each patient who met the inclusion criteria received the envelope he opened the small piece of paper with the number and corresponding treatment written inside. The patients then go to the corresponding treatment department to receive intervention according to the contents of the small piece of paper and then wait until a week later to draw lots again to enter the next group to receive intervention and so on.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

http://www.medresman.org.cn/uc/index.aspx

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management: First the information is collected through transcranial magnetic stimulation-induced action potential activity plate and uploaded and saved in the computer. The second is to collect information through the case record form and save the data and upload it to ResMan.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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