prolonged disorders of consciousness
Conditions
Interventions
TIS stimulation group:On the basis of the conventional treatment protocol for promoting wakefulness, TIS stimulation is carried out once a day, five times a week, for a total of four weeks.
TIS sham stimulation group:The appearance of the device and the operation process are similar to those of the real stimulation group, but in fact, no effective electrical current stimulation is delive
Sponsors
The Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1)The age is >= 18 years old; (2)The main pathogenic factor is craniocerebral injury, which is confirmed by craniocerebral CT and/or MRI examination. The patient is accompanied by a disorder of consciousness, and the pathogenic factors are traumatic, stroke-related, and hypoxic-ischemic; (3)The course of the disorder of consciousness is >= 28 days; (4)The level of the disorder of consciousness is evaluated as vegetative state (VS) or minimally conscious state (MCS) according to the Coma Recovery Scale-Revised (CRS-R) scale; (5)The vital signs are stable; (6)The family members of the patient are voluntarily informed and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with critical illness and unstable vital signs; (2)Active intracerebral hemorrhage; (3)Patients with indwelling metallic objects in the intracranial cavity; (4)Patients with a cardiac pacemaker in the body; (5)Disorders of consciousness caused by other reasons; (6) A history of epilepsy or a family history of epilepsy in the past; (7) Patients with severe failure of important organs such as the heart, liver, and kidneys; (8) Incomplete skull.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revised scores, CRS-R;electroencephalogram results;functional magnetic resonance imaging, fMRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow coma scale, GCS;Full Outline of Unresponsiveness Score, FOUR;Extended Glasgow Outcome Scale, GOS-E;Somatosensory evoked potential, SEP;brainstem auditory evoked potential, BAEP;Visual evoked potential, VEP; | — |
Countries
China
Contacts
Public ContactPu Wang
The Seventh Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed