Menu
Not yet recruiting NCT06927336

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

Phase IV Interventional tDCS Cerebellum Brain Injury Disturbance of Consciousness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XinNaoJing injection, tDCS.
Who it may be relevant to
Registry conditions: tDCS, Cerebellum, Brain Injury, Disturbance of Consciousness. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • electroencephalogram [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Oxygenated hemoglobin concentration (HbO) [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (12)
  • RLA grading Scale [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Glasgow Coma Scale (GCS) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Coma Recovery Scale-Revised (CRS-R) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • FOUR Score (Full Outline of UnResponsiveness) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Nutritional Risk Screening (NRS 2002) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Functional Independence Measure (FIM) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Albumin [Time frame: From enrollment to the end of treatment at 2 weeks]
  • S100β [Time frame: From enrollment to the end of treatment at 2 weeks]
  • NSE (Neuron-Specific Enolase) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • NFL (Neurofilament Light Chain) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Tau Protein [Time frame: From enrollment to the end of treatment at 2 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Electroencephalography — Kunming

Identifiers

NCT: NCT06927336 · Shen-PJ-Ke-2025-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗