NCT06927336

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Second Affiliated Hospital of Kunming Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• tDCS
• Cerebellum
• Brain Injury
• Disturbance of Consciousness

Interventions

Type	Name	Description
DRUG	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.
DEVICE	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.

Timeline

• Start date: 2025-04-25
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: China