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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liqing Yao | Contact | +8613529202383 | yaoliqing98731@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Electroencephalography | Kunming | Yunnan | China |
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| 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. |
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| 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 |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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