The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury

NCT ID: NCT06927336

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-12-30

Brief Summary

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The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.

Detailed Description

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Conditions

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tDCS Cerebellum Brain Injury Disturbance of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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tDCS combined with XingNaoJing treatment group

The tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, the stimulation intensity was 2mA, and the stimulation site was the cerebellum. The dosage of Xingnaojing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day. Intervention for two weeks.

Group Type EXPERIMENTAL

XinNaoJing injection

Intervention Type DRUG

XingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates blood stasis and cleans heat; Both are subject medicine. Natural musk cleans the brain, Shujin Tongluo, Jun medicine; Borneol awaken awaken, for adjuvant. Small doses of musk restored brain function and improved cerebral circulation. Xingnaojing injection can promote the recovery of consciousness, reduce the level of plasma β-endorphin, and restore brain function. Borneol bi-dimensionally regulates the central nervous system, calms, prolongs the level of arousal, and protects the brain tissue.

tDCS

Intervention Type DEVICE

tDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.

tDCS treatment group

The tDCS stimulation time was 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

tDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.

XingNaoJing treatment group

The dosage of XingNaoJing was 20 ml each time by intravenous drip, diluted with 9% sodium chloride injection 200 ml, once a day.

Group Type SHAM_COMPARATOR

XinNaoJing injection

Intervention Type DRUG

XingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates blood stasis and cleans heat; Both are subject medicine. Natural musk cleans the brain, Shujin Tongluo, Jun medicine; Borneol awaken awaken, for adjuvant. Small doses of musk restored brain function and improved cerebral circulation. Xingnaojing injection can promote the recovery of consciousness, reduce the level of plasma β-endorphin, and restore brain function. Borneol bi-dimensionally regulates the central nervous system, calms, prolongs the level of arousal, and protects the brain tissue.

Interventions

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XinNaoJing injection

XingNaoJing injection is a kind of traditional Chinese medicine preparation, which has the effects of clearing heat and detoxifying, cooling blood and activating blood circulation, resuscitating the brain. In recent years, it has been often used in the treatment of related symptoms caused by qi and blood disturbance and cerebral blood stasis, and has achieved certain results. Xingnaojing injection contains Yujin to resuscitate phlegm, invigorate blood circulation and promote qi; Zhizi dissipates blood stasis and cleans heat; Both are subject medicine. Natural musk cleans the brain, Shujin Tongluo, Jun medicine; Borneol awaken awaken, for adjuvant. Small doses of musk restored brain function and improved cerebral circulation. Xingnaojing injection can promote the recovery of consciousness, reduce the level of plasma β-endorphin, and restore brain function. Borneol bi-dimensionally regulates the central nervous system, calms, prolongs the level of arousal, and protects the brain tissue.

Intervention Type DRUG

tDCS

tDCS stimulated the cerebellum for 20 minutes, once a day, 5 times a week, a total of 10 times, and the stimulation intensity was 2mA.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. aged 18-80 years;
2. All patients met the diagnostic criteria of DoC;
3. more than 1 month after the initial head injury;
4. stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
5. no skull defect or large area of skull repair;
6. The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.

Exclusion Criteria

1. supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
2. a life expectancy of less than 3 months or a follow-up of less than 3 months;
3. retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
4. EEG recording with significant muscle artifacts and inhibitory bursts;
5. nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
6. disturbance of consciousness due to surgical injury or tumor.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role lead

Responsible Party

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Liqing Yao

Department of rehabilitation medicine, the Second Affiliated Hospital of Kunming Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Electroencephalography

Kunming, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Liqing Yao

Role: CONTACT

+8613529202383

Facility Contacts

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Yao

Role: primary

+8613529202383

Other Identifiers

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Shen-PJ-Ke-2025-6

Identifier Type: -

Identifier Source: org_study_id

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