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

Kunming Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Brain Injury; Cerebellum; Disturbance of Consciousness; tDCS

Treatments: Drug: XinNaoJing injection; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06927336

Shen-PJ-Ke-2025-6

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 3 patient groups

tDCS combined with XingNaoJing treatment group

Experimental group

Description:

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.

Treatment:

Device: tDCS

Drug: XinNaoJing injection

tDCS treatment group

Sham Comparator group

Description:

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.

Treatment:

Device: tDCS

XingNaoJing treatment group

Sham Comparator group

Description:

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

Treatment:

Drug: XinNaoJing injection