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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
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.
Electroencephalography
Kunming, Yunnan, China
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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 2 weeks
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to the end of treatment at 2 weeks
Albumin
Albumin in g/L
Time frame: From enrollment to the end of treatment at 2 weeks
S100β
S100β in ng/mL
Time frame: From enrollment to the end of treatment at 2 weeks
NSE (Neuron-Specific Enolase)
NSE (Neuron-Specific Enolase) in ng/mL
Time frame: From enrollment to the end of treatment at 2 weeks
NFL (Neurofilament Light Chain)
NFL (Neurofilament Light Chain) in pg/mL
Time frame: From enrollment to the end of treatment at 2 weeks
Tau Protein
Tau Protein in pg/mL
Time frame: 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
Time frame: From enrollment to the end of treatment at 2 weeks
GFAP (Glial Fibrillary Acidic Protein)
GFAP (Glial Fibrillary Acidic Protein) in ng/mL
Time frame: 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
Time frame: From enrollment to the end of treatment at 2 weeks
ALT (Alanine Aminotransferase)
ALT (Alanine Aminotransferase) in U/L
Time frame: From enrollment to the end of treatment at 2 weeks
AST (Aspartate Aminotransferase)
AST (Aspartate Aminotransferase) in U/L
Time frame: From enrollment to the end of treatment at 2 weeks
Vitamin B12
Vitamin B12 in pg/mL
Time frame: From enrollment to the end of treatment at 2 weeks
Thiamine (Vitamin B1)
Thiamine (Vitamin B1) in nmol/L
Time frame: From enrollment to the end of treatment at 2 weeks
Vitamin D
Vitamin D in ng/mL
Time frame: From enrollment to the end of treatment at 2 weeks
Phosphate
Phosphate in mg/dL.
Time frame: From enrollment to the end of treatment at 2 weeks
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