severe traumatic brain injury
Conditions
Interventions
Experimental:valproate acid(VPA)
Control:placebo
Sponsors
Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Eligible patients were 16 to 65 years of age with all genders; 2. The patients had sustained a nonpenetrating traumatic brain injury 4 to 16 weeks before enrollment, with the confirmation of CT or MRI; 3. Additional eligibility criteria were a vegetative state or a minimally conscious state, as indicated by a Disability Rating Scale (DRS) score greater than 11; 4. There was an inability both to follow commands consistently and to engage in functional communication, as assessed by the score on the Coma Recovery Scale–Revised (CRS-R); 5. All the patients had provided written informed consent; 6. The patients were receiving usual inpatient rehabilitation and treatment at each site.
Exclusion criteria
Exclusion criteria: 1. unstable health state,including: Be allergic to VPA, or with serious allergic diseases or allergic constitutions; With serious cardiovascular diseases, hepatic, renal, or psychiatric diseases; With serious respiratory, endocrine, or blood system diseases; With serious infections or malignant tumors; With weakened immunologic status; Addison’s diseases; With alcohol or drug abuse. 2. Any disability related to the central nervous system that predated the traumatic brain injury; 3. Pregnancy or breastfeeding females; 4. More than one seizure in the previous month; 5. Prior treatment with VPA; 6. In the case of patients who were undergoing evaluation for ventricular shunt placement or receiving a psychoactive medication, enrollment was deferred until shunt placement had been completed or psychoactive medications discontinued; 7. The patients had enrolled the other studies in the past three months or are engaging the other studies; 8. The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DRS scale;CRS-R scale;The frequency and severity of epilepsy;The effective blood drug concentration monitoring of VPA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nerve physiological reflex;Nerve pathological reflex;limb muscle strength checking;limb muscle tone checking;Blood routine test;routine urine test;stool routine test;liver function examination;kidney function examination;EKG;blood sugar test;blood lipids;Routine, biochemical and cytological examination; | — |
Countries
China
Contacts
Public ContactFei Zhou
Outcome results
None listed