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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injury; tDCS; Cerebellum; Disturbance of Consciousness
• Intervention / Treatment: Drug: XinNaoJing injection; Device: tDCS

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liqing Yao; Phone Number: +8613529202383; Email: yaoliqing98731@163.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Electroencephalography
      • Contact: Yao; Phone Number: +8613529202383; Email: yaoliqing98731@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS combined with XingNaoJing treatment group; 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; 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.; 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.
Sham Comparator: tDCS treatment group; 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; 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.
Sham Comparator: XingNaoJing treatment group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
RLA grading Scale	Purpose: Used to assess the level of consciousness in patients after brain injury, especially those in comatose or vegetative states. Scoring: The scale has 10 levels, each representing different levels of awareness and functioning. Level 1: No response (Coma) - No response to external stimuli. Level 2: Generalized response - Non-specific responses to stimuli. Level 3: Localized response - Specific responses to stimuli. Level 4: Confused-agitated - Disoriented and agitated behavior. Level 5: Confused-inappropriate - Inappropriate responses to commands, confusion. Level 6: Confused-appropriate - Appropriate responses but still confused. Level 7: Automatic-appropriate - Performs tasks automatically but still lacks flexibility. Level 8: Purposeful-appropriate - Independent with a certain level of awareness. Level 9: Purposeful-appropriate (standby assistance) - Increased independence. Level 10: Purposeful-appropriate (modified independent) - Fully independent.	From enrollment to the end of treatment at 2 weeks
Glasgow Coma Scale (GCS)	Purpose: Assesses the neurological function and level of consciousness in patients, particularly those in a comatose state. Scoring: The scale evaluates three components: Eye response (E), Verbal response (V), and Motor response (M). Each component is scored from 1 to 4, and the total score is calculated. Eye response (E): 4 (spontaneous opening) to 1 (no response). Verbal response (V): 5 (oriented speech) to 1 (no response). Motor response (M): 6 (obeys commands) to 1 (no response). Total score: Ranges from 3 (deep coma) to 15 (fully alert and responsive).	From enrollment to the end of treatment at 2 weeks
Coma Recovery Scale-Revised (CRS-R)	Purpose: Used to assess recovery in patients with severe brain injuries or in vegetative states. Scoring: Consists of 23 items evaluating different types of responses such as visual, auditory, and motor responses. Score range: 0 (no response) to 23 (full recovery). Components: The scale evaluates awareness, attention, perception, language, and motor responses.	From enrollment to the end of treatment at 2 weeks
FOUR Score (Full Outline of UnResponsiveness)	Purpose: Used to assess the neurological status of patients with impaired consciousness, particularly those unable to communicate verbally. Scoring: Includes four parameters: Eye response, Brainstem reflexes, Respiratory pattern, and Motor response. Each parameter is scored from 0 to 4. Eye response: 0 (no response) to 4 (spontaneous eye opening). Brainstem reflexes: 0 (no reflexes) to 4 (normal reflexes). Respiratory pattern: 0 (no breathing) to 4 (spontaneous breathing). Motor response: 0 (no movement) to 4 (voluntary movement). Total score: Ranges from 0 (no response) to 16 (normal response).	From enrollment to the end of treatment at 2 weeks
Nutritional Risk Screening (NRS 2002)	Purpose: Used to assess the nutritional risk of hospitalized patients. Scoring: The scale includes factors like disease severity, weight loss, and appetite. Disease severity: 0 (no disease) to 3 (severe disease). Appetite loss: 0 (no loss) to 3 (severe loss of appetite). Weight loss: 0 (no weight loss) to 3 (significant weight loss). Total score: A score of 3 or more indicates moderate to high nutritional risk.	From enrollment to the end of treatment at 2 weeks
Thrombosis Risk Assessment Scale (Padua Risk Assessment Scale)	Purpose: Used to assess the risk of deep vein thrombosis (DVT) in hospitalized patients. Scoring: Includes clinical factors like age, obesity, cancer, and bed rest. Risk score: 0 (low risk) to 3 or more (high risk). Common factors: Advanced age, immobility, surgery, obesity, and malignancy are some factors that increase the risk.	From enrollment to the end of treatment at 2 weeks
Functional Independence Measure (FIM)	Purpose: Assesses a patient's ability to perform activities of daily living, often used in rehabilitation settings. Scoring: Includes 13 items assessing daily living tasks (eating, dressing, bathing, toileting) and 5 cognitive tasks (social interaction, problem-solving). Score range: 1 (total dependence) to 7 (total independence). Total score: The lowest possible score is 18 (completely dependent) and the highest is 126 (completely independent).	From enrollment to the end of treatment at 2 weeks
Albumin	Albumin in g/L	From enrollment to the end of treatment at 2 weeks
S100β	S100β in ng/mL	From enrollment to the end of treatment at 2 weeks
NSE (Neuron-Specific Enolase)	NSE (Neuron-Specific Enolase) in ng/mL	From enrollment to the end of treatment at 2 weeks
NFL (Neurofilament Light Chain)	NFL (Neurofilament Light Chain) in pg/mL	From enrollment to the end of treatment at 2 weeks
Tau Protein	Tau Protein in pg/mL	From enrollment to the end of treatment at 2 weeks
Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1)	Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) in ng/mL	From enrollment to the end of treatment at 2 weeks
GFAP (Glial Fibrillary Acidic Protein)	GFAP (Glial Fibrillary Acidic Protein) in ng/mL	From enrollment to the end of treatment at 2 weeks
CK-MB (Creatine Kinase MB Isoform)	CK-MB (Creatine Kinase MB Isoform) in U/L	From enrollment to the end of treatment at 2 weeks
ALT (Alanine Aminotransferase)	ALT (Alanine Aminotransferase) in U/L	From enrollment to the end of treatment at 2 weeks
AST (Aspartate Aminotransferase)	AST (Aspartate Aminotransferase) in U/L	From enrollment to the end of treatment at 2 weeks
Vitamin B12	Vitamin B12 in pg/mL	From enrollment to the end of treatment at 2 weeks
Thiamine (Vitamin B1)	Thiamine (Vitamin B1) in nmol/L	From enrollment to the end of treatment at 2 weeks
Vitamin D	Vitamin D in ng/mL	From enrollment to the end of treatment at 2 weeks
Phosphate	Phosphate in mg/dL.	From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Consciousness Disorders
• Other Study ID Numbers: Shen-PJ-Ke-2025-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No