Clinical trial NCT06927336: The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
Official title: The Study on the Efficacy of tDCS Stimulation of the Cerebellum Combined With XingNaoJing Injection in Patients With Consciousness Disorders After Cranial Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: tDCS
Cerebellum
Brain Injury
Disturbance of Consciousness
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: electroencephalogram
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Oxygenated hemoglobin concentration (HbO)
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: RLA grading Scale
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Glasgow Coma Scale (GCS)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: FOUR Score (Full Outline of UnResponsiveness)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Nutritional Risk Screening (NRS 2002)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Functional Independence Measure (FIM)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Albumin
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: S100β
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: NSE (Neuron-Specific Enolase)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: NFL (Neurofilament Light Chain)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Tau Protein
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: GFAP (Glial Fibrillary Acidic Protein)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: CK-MB (Creatine Kinase MB Isoform)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: ALT (Alanine Aminotransferase)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: AST (Aspartate Aminotransferase)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Vitamin B12
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Thiamine (Vitamin B1)
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Vitamin D
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Phosphate
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
Locations:
city: Kunming
country: China
facility: Electroencephalography
state: Yunnan
Study officials:
References: