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
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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NOT_YET_RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2025-04-25
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Kunming Medical University
OTHER
Responsible Party
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Liqing Yao
Department of rehabilitation medicine, the Second Affiliated Hospital of Kunming Medical University
Locations
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Electroencephalography
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Shen-PJ-Ke-2025-6
Identifier Type: -
Identifier Source: org_study_id
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