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

NCT06927336 | Not Yet Recruiting Phase 4

• 1 other identifier: Shen-PJ-Ke-2025-6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• electroencephalogram

  Event-related potential: MMN and P300 in uV; Changes in power spectra and coherence and phase synchronization under delta, theta, and alpha in uV2.

  From enrollment to the end of treatment at 2 weeks

• Oxygenated hemoglobin concentration (HbO)

  Near-red function test fNRIS: to understand the changes of oxygen saturation in the head. HbO in uM.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (21)

• RLA grading Scale

  From enrollment to the end of treatment at 2 weeks

• Glasgow Coma Scale (GCS)

  From enrollment to the end of treatment at 2 weeks

• Coma Recovery Scale-Revised (CRS-R)

  From enrollment to the end of treatment at 2 weeks

• FOUR Score (Full Outline of UnResponsiveness)

  From enrollment to the end of treatment at 2 weeks

• Nutritional Risk Screening (NRS 2002)

  From enrollment to the end of treatment at 2 weeks

Study Arms (3)

tDCS combined with XingNaoJing treatment group

EXPERIMENTAL

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.

Drug: XinNaoJing injection; Device: tDCS

tDCS treatment group

SHAM COMPARATOR

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.

Device: tDCS

XingNaoJing treatment group

SHAM COMPARATOR

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

Drug: XinNaoJing injection

Interventions

XinNaoJing injection 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.

XingNaoJing treatment group; tDCS combined with XingNaoJing treatment group

tDCS 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 combined with XingNaoJing treatment group; tDCS treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Electroencephalography

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Liqing Yao

CONTACT

+8613529202383; yaoliqing98731@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of rehabilitation medicine, the Second Affiliated Hospital of Kunming Medical University

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 15, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)