Early disorders of consciousness Mental and Behavioural Disorders
Conditions
Interventions
The random sequence was generated by SPSS 24.0 software. The patients were divided into 4 groups according to the enrollment ratio of 1:1:1:1. The treatment period is two weeks. A follow-up visit will
Sponsors
Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with consciousness disorders caused by traumatic brain injury, ischemic hypoxic encephalopathy and cerebrovascular diseases 2. All are first-time cases, with a disease course within 28 days 3. Age between 18 and 80 years old 4. The patients' families are informed, voluntarily participate and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with critical condition and unstable vital signs/unstable mental state (showing signs of spontaneous recovery or deterioration within 1 week) 2. Patients with severe arrhythmia or those with implanted cardiac pacemakers 3. Patients with metal objects in the brain 4. Patients with active intracranial hemorrhage 5. Patients with a history of epilepsy or a family history of epilepsy 6. Patients with skull defects at the stimulation site, those who have undergone skull metal material repair, or those with local infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of the patient's coma measured using the Glasgow Coma Scale (GCS), comprising three items: eye-opening response (E, up to 4 points), verbal response (V, up to 5 points), and motor response (M, up to 6 points), at within 24 hours after enrollment and after 2 weeks of treatment;Neurobehavioral function measured using the Coma Recovery Scale-Revised (CRS-R) , comprising six sub-items including movement, auditory, speech, vision, communication and arousal level, with scores ranging from 0 to 23 points, at within 24 hours after enrollment and after 2 weeks of treatment;Electrical activity in the brain measured using electroencephalogram (EEG), comprising 24-channel electrodes placed using the international 10/20 system standard. The grading of consciousness disorders was based on the Synek grading standard of EEG at within 24 hours after enrollment and after 2 weeks of treatment.;Pre-attentional processing and sensory memory traces measured using Mismatch Negativity (MMN) (passive Oddball paradigm): the amplitude, latency, and occurrence rate of MMN waves in the frontal-central area at within 24 hours after enrollment and after 2 weeks of treatment;Amplitude, latency and occurrence rate of the P3a wave in the superior central area measured using the Medical Event-Related Potential Instrument, Model WJ-1B, at within 24 hours after enrollment and after 2 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy measured using comprehensive assessment of standardized behavioral scales, neurological functional changes, and functional recovery levels at after 2 weeks of treatment;Safety measured using the incidence rates of adverse events such as epileptic seizures, local skin burns, arrhythmias, cardiac arrest, hemodynamic changes, decreased oxygen saturation, removal of tracheal intubation or internal tubes, and worsening of the condition in patients at after 2 weeks of treatment | — |
Countries
China
Contacts
Public ContactLong Zhao
Outcome results
None listed