chronic consciousness disorders
Conditions
Interventions
treatment group:Stimulation on after 14(+/-3)days of implantation
Sponsors
Fudan University HuaShan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged 18-80 years; 2) patients with MCS who could be diagnosed according to the Coma Recovery Scale-Revision (CRS-R); 3) Patients with a duration of craniocerebral trauma for more than 6 months or a non-traumatic brain injury for more than 3 months, and no progressive improvement or deterioration of consciousness for more than 4 consecutive weeks; 4) Normal body temperature, stable condition, stable internal environment; 5) At least one thalamus and PCC/PCu brain area have no obvious structural and functional damage; 6) Obtain written informed consent from the legal representative or guardian of the DoC patient in advance
Exclusion criteria
Exclusion criteria: 1) Patients with functional disabilities caused by developmental disorders, mental diseases, and neurological diseases before brain injury. 2) severe deformation of brain structure; 3) Patients with untreated hydrocephalus, skull defects and other known serious diseases (such as multiple organ failure, obvious cardiac insufficiency, severe lung inflammation) that affect the improvement of their condition or complete follow-up; 4) Patients who have undergone hydrocephalus and aneurysm clipping, and have MRI incompatible hardware; 5) Those with contraindications to DBS surgery; 6) Those who have participated in other clinical trials; 7) Patients with hypoxic encephalopathy caused by asphyxia, cardiorespiratory arrest; 8) Those who have an estimated life expectancy of less than 1 year; 9) patients whose investigators assessed the risks of DBS treatment were much greater than those benefiting; 10) Pregnant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the patient's CRS-R score compared with the preoperative baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the patient's CRS-R score compared with the preoperative baseline;Patient's CRS-R score;The change in Multimodal MRI compared with the preoperative baseline;The change in high-density EEG (resting-state, Chinese semantic paradigm) compared with the preoperative baseline ; | — |
Countries
China
Contacts
Public ContactMao Ying
Fudan University HuaShan Hospital
Outcome results
None listed