Effect of Sensorimotor Cortex Integration in Motor Learning Induced By Acupuncture

Registration number:

ITMCTR2100005459

Date of Last Refreshed on:

2021-12-28

Date of Registration:

2021-12-28

Registration Status:

Prospective registration

Public title:

Effect of Sensorimotor Cortex Integration in Motor Learning Induced By Acupuncture

English Acronym:

Scientific title:

Effect of Sensorimotor Cortex Integration in Motor Learning Induced By Acupuncture

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100054850 ; ChiMCTR2100005459

Applicant:

Qiwen Zou、Zhanmou Liang

Study leader:

Jianhua Liu

Applicant telephone:

+86 13580587539

Study leader's telephone:

+86 13729889452

Applicant Fax:

Study leader's fax:

Applicant E-mail:

463011513@qq.com

Study leader's E-mail:

jyhf08@sina.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Department of Acupuncture and Moxibustion, Guangdong Provincail Hospital of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

BF2021-203-01

Approved file of Ethical Committee:

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

Date of approved by ethic committee:

2021/10/22 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Guangdong Provincail Hospital of Traditional Chinese Medicine

Primary sponsor's address:

111 Dade Road, Yuexiu District

Secondary sponsor:

Country:

China

Province:

Guangdong

City:

guangzhou

Institution
hospital:

Guangdong Provincail Hospital of Traditional Chinese Medicine

Address:

111 Dade Road, Yuexiu District

Source(s) of funding:

National Natural Science Foundation of China No.81873381

Target disease:

no

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(cross-over design)

Study phase:

Pilot clinical trial

Objectives of Study:

To Observe the Effect of Sensorimotor Cortex Integration in Motor Learning Induced by Acupuncture

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(1)1. Healthy subjects, aged from 18 to 35; 2. Right handed subjects, regardless of gender; 3. Patients without neurological, mental and motor diseases in the past; 4. Subjects who have not received any peripheral stimulation (such as acupuncture, peripheral electrical stimulation, etc.) or central stimulation (such as rTMS, tDCS, etc.) in the past 3 months; 5. Subjects who are willing to accept electroacupuncture and have no history of acupuncture sickness; 6. Subjects who voluntarily participated in this study and signed informed consent.

Exclusion criteria:

(2)1.Patients with mental system diseases, such as schizophrenia, anxiety disorder, personality disorder, etc; 2. Patients with nervous system diseases, such as brain trauma, posterior cranial fossa disease, spasm, trigeminal neuralgia, Jackson epilepsy, spasm after facial paralysis, blepharospasm, cognitive impairment, speech disorder and dementia, etc; 3. Patients with history of severe hypertension, diabetes, malignant tumor, and other diseases of heart, liver, kidney and other organs; 4. Patients with metal residues (including denture, pacemaker, nerve stimulator, medical pump, etc.); 5. Subjects who were afraid of TMS and could not be stimulated by TMS for other reasons; 6. Subjects who are afraid of acupuncture or have adverse reactions to acupuncture; 7. Pregnant or lactating women.

Study execute time:

From 2021-12-27

To      2022-05-23

Recruiting time:

From 2021-12-27

To      2022-05-23

Interventions:

20

Group:

1

Sample size:

1

Intervention:

electrial acupuncture in HEGU for 30 minutes?

Intervention code:

20

Group:

2

Sample size:

Intervention:

after received 1HZ repetitive TMS inhibiting the sensory cortex, electroacupuncture Hegu for 30 minutes

Intervention code:

20

Group:

3

Sample size:

Intervention:

sham acupuncture HEGUfor 30 minutes?

Intervention code:

Total sample size : 20

Countries of recruitment
and research settings:

Country:

China

Province:

Guangdong

City:

guangzhou

Institution/hospital:

Guangdong Provincail Hospital of Traditional Chinese Medicine

Level of the institution:

3A

Outcomes:

Outcome:

Motor evoked potential

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Samatosensory evoked potentials

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Serial reaction time task

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

凹槽钉学习

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Motor threshold

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Not yet recruiting

18
Min age years
35
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

Grouping takes a simple randomization approach, applying the PEMS3.1 for Windows "completely random (two and multiple groups) design" program to produce random numbers (total number of subjects = 20, number of processing groups = 3), obtain sequential numbers, make random cards, and seal envelopes.

Blinding:

IPD sharing:

Yes

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

Resman, http://www.medresman.org

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

The data includes the using excel records of CRF. The Resman database will be used.

Data Managemen Committee:

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above