Prolonged disorders of consciousness
Conditions
Interventions
Trial Group:Lingnan Jiejing therapy eye acupuncture: selecting 13 points in 8 zones around the eyes. Specific procedure: using three acupuncture needles held together, starting from the lung meridian
median nerve electrical stimulation
'From Yin to Yang' large meridian connecting awakening technique (acupuncture at Baihui, Neiguan, Shuigou, etc., followed by pulse stimulation and retention for 30 minutes)
rehabilitation training (electric standing bed, passive movements).
Control Group:Conventional acupuncture for awakening. Main points: bilateral Fengchi, Wangu, Tianzhu, Yamen, Fugue
auxiliary points: Shuigou, Sishencong, Zhisanpin, Tiansanpin, Neiguan, Baihui, Jiquan, Weizhong, Quchi, Sanyinjiao, Zusanli. Specific procedures: Neiguan with twisting-reducing method for 1 minute
Shuigou with twisting-stagnation and flicking-reducing method until lacrimation occurs
Fengchi with transcutaneous needling
Wangu, Tianzhu, Yamen, Fugue with twisting-reducing method, straight insertion to 1 cun depth. Electroacupuncture with sparse-dense wave stimulation
other points with conventional techniques, retaining needles for 30 seconds with twisting motion at about 200 times per minute. Retain needles for 30 minutes, once daily. Basic treatment consistent wi
Sponsors
Guangdong Provincial Second Hospital of Traditional Chinese Medicine (The Fifth Clinical Medical College of Guangzhou University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. First-time traumatic brain injury (TBI) in patients aged 18–80 years. 2. Patients diagnosed with internal head injury (Phlegm-Stasis Blocking Collaterals syndrome) according to Traditional Chinese Medicine (TCM) criteria: (1) History of direct or indirect head trauma; (2) Post-injury symptoms such as coma, restlessness, dizziness, headache, nausea, and vomiting; (3) Injury location and severity confirmed by history, physical examination, CT, and MRI, referencing the TCM Industry Standard of the People's Republic of China "Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes" (ZY/T001.1-94). 3. Disease onset within 1 year, meeting diagnostic criteria for Minimally Conscious State (MCS): following simple commands; answering yes/no via gestures or speech regardless of accuracy; intelligible verbalization; purposeful behavior (including contingent movements and emotional responses to environmental stimuli, distinct from involuntary movements); clear history of trauma, categorized as primary TBI (immediate damage such as scalp injuries, skull fractures, concussion, cerebral contusion/laceration) and secondary TBI (progressive damage such as intracranial hematoma and cerebral edema). Western medical criteria reference "Neurosurgery" (Edited by Zhao Jizong, People's Medical Publishing House, 2007). 4. No metallic implants or pacemakers in the body. 5. No infection, bleeding points, or skin breakdown at the treatment site. 6. No history of epilepsy, drug abuse, or alcoholism. 7. No injury to the right median nerve, brachial plexus, or cervical spinal cord. 8. No organic impairment of vision or hearing organs. 9. Patient and/or legal guardians agree to participate in the clinical trial, demonstrate high compliance and active cooperation, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pre-existing severe dementia, developmental disability, progressive neurodegenerative disease, or other underlying diseases that may substantially interfere with consciousness assessment. 2. Open cranial trauma, major skull defect, severely poor scalp condition, or other conditions preventing EEG acquisition. 3. Severe eyelid trauma, periocular infection, obvious facial injury, persistent facial obstruction, or other conditions preventing video-behavioral acquisition and rating. 4. Status epilepticus or frequent clinically overt seizures within the previous 72 hours. 5. Requirement for continuous deep sedation, unstable vital signs, or severe heart, lung, liver, or kidney failure. 6. Planned addition of other specialized arousal-promoting treatments during the study period, including but not limited to transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, or hyperbaric oxygen therapy. 7. Any other condition judged by the investigators to make the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total Coma Recovery Scale-Revised (CRS-R) score from baseline to Day 14; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate at Day 14;Improvement rate in consciousness-state classification at Day 14;Changes in EEG features at Day 14;Changes in standardized video-behavioral indicators at Day 14; | — |
Countries
China
Contacts
Public ContactChi Xiangfeng
Guangdong Provincial Second Hospital of Traditional Chinese Medicine (The Fifth Clinical Medical College of Guangzhou University of Chinese Medicine)
Outcome results
None listed