Status:
NOT_YET_RECRUITING
The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
Lead Sponsor:
The Second Affiliated Hospital of Kunming Medical University
Conditions:
tDCS
Cerebellum
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 cla...
Eligibility Criteria
Inclusion
- aged 18-80 years;
- All patients met the diagnostic criteria of DoC;
- more than 1 month after the initial head injury;
- stable consciousness for at least 2 weeks before admission (no change in CRS-R total score);
- no skull defect or large area of skull repair;
- The legal representative authorized by the patient approved the experimental protocol and signed the informed consent form.
Exclusion
- supratentorial abnormalities on computed tomography (CT) or magnetic resonance imaging (MRI) involving more than one third of the middle cerebral artery territory;
- a life expectancy of less than 3 months or a follow-up of less than 3 months;
- retention of intracranial metal objects, cranial debridement, or presence of cranial defects and any clinically significant or unstable medical diseases;
- EEG recording with significant muscle artifacts and inhibitory bursts;
- nonconvulsive status epilepticus; Periodic or burst rhythms evoked by stimulation;
- disturbance of consciousness due to surgical injury or tumor.
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06927336
Start Date
April 25 2025
End Date
December 30 2026
Last Update
April 15 2025
Active Locations (1)
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1
Electroencephalography
Kunming, Yunnan, China