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Trigeminal nerve stimulation and acupuncture for prolonged disorders of consciousness

Registration number：

ITMCTR2024000562

Date of Last Refreshed on：

2024-10-15

Date of Registration：

2024-10-15

Registration Status：

Prospective registration

Public title：

Trigeminal nerve stimulation and acupuncture for prolonged disorders of consciousness

English Acronym：

Scientific title：

Trigeminal nerve stimulation and acupuncture for prolonged disorders of consciousness

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Huiyi Huang

Study leader：

Shaoling Wu

Applicant telephone：

13539997775

Study leader's telephone：

13660183777

Applicant Fax：

Study leader's fax：

Applicant E-mail：

489615911@qq.com

Study leader's E-mail：

13660183777@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Yanjiangxi Road No.107 guangzhou guangdong

Study leader's address：

Yanjiangxi Road No.107 guangzhou guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Approved by ethic committee：

Approved No. of ethic committee：

SYSKY-2023-1284-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Date of approved by ethic committee：

2024/2/4 0:00:00

Contact Name of the ethic committee：

Liushan Ou

Contact Address of the ethic committee：

Yanjiangxi Road No.107 guangzhou guangdong

Contact phone of the ethic committee：

020-81332587

Contact email of the ethic committee：

sysyxllwyh@163.com

Primary sponsor：

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Primary sponsor's address：

Yanjiangxi Road No.107 yuexiu district Guangzhou Guangdong China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Institution
hospital：

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Address：

Yanjiangxi Road No.107, yuexiu district, Guangzhou, Guangdong, China

Source(s) of funding：

Major Innovation Technology Construction Project of Synergistic Chinese Medicine and Western Medicine of Guangzhou (No.2023-2318)

Target disease：

prolonged disorders of consciousness

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To observe the efficacy of trigeminal nerve stimulation and acupuncture in the treatment of prolonged disorders of consciousness and to investigate its mechanism.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) age ≥ 18 years; ;(2) diagnosed as vegetative state (VS) or minimally consciousness state (MCS) according to the clinical diagnostic criteria and coma recovery scale-revised (CRS-R); (3) duration of loss of consciousness＞28 days; (4) patient's family members voluntarily participate in the project and sign the informed consent.

Exclusion criteria：

(1) long-term dependence on sedatives anesthetics and other drugs that significantly affect the assessment of conscious states; (2) contraindications in electromagnetic related treatment such as the use of implantable electronic devices (such as pacemakers); (3) skull defect; (4) local skin injury or infection; (5) combined with serious mental illness epilepsy; (6) combined with other serious diseases of the system (such as heart liver kidney and other function failure or serious infection).

Study execute time：

From 2024-10-30

To      2026-12-31

Recruiting time：

From 2024-10-30

To      2026-12-31

Interventions：

30

Group：

TNS+ sham acupuncture

Sample size：

Intervention：

TNS+ sham acupuncture

Intervention code：

30

Group：

TNS+acupuncture

Sample size：

Intervention：

TNS+acupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

广州市越秀区沿江西路107号

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Evoked potential

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

CRS-R score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

GCS score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Near infrared functional imaging

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Random sequences were generated by computer software by data managers who were blinded to the project design.

Blinding：

Participants outcome evaluators and statisticians were blinded in grouping assignments.

IPD sharing：

No

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

None

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

We will collect data through Case Report Form（CRF）.

Data Managemen Committee：

Not yet

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

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