Disorders of consciousness following traumatic brain injury
Conditions
Interventions
TNS Group:Low-frequency electrical stimulation of the trigeminal nerve using a portable biofeedback stimulator (S430) with current intensity of 10-15mA, frequency of 40Hz, pulse width of 200µs
treatment mode: repeated 30s on and 30s off
course duration of 4 weeks, 5 days per week, 1 hour per session
Sham stimulation group:Stimulation device connected to the patient's face with device display kept on, current set to 0mA
other stimulation parameters identical to those in the TNS group
Sponsors
First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. TBI as the primary causative factor, confirmed by CT and/or MRI as the initial event, accompanied by DOC; 3. Duration of DOC ranging from 37 days to 6 months; 4. Level of DOC assessed as vegetative state or minimally conscious state using the CRS-R; 5. Willingness to participate and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. DOC attributed to causes other than TBI; 2. Severe cardiac, pulmonary, hepatic, or renal dysfunction; 3. Unstable vital signs or deterioration of condition due to new lesions; 4. Concomitant severe medical diseases or severe bleeding tendency; 5. Presence of intracranial metallic foreign bodies; 6. Presence of a cardiac pacemaker in vivo; 7. History of epilepsy or a family history of epilepsy; 8. Patients who decline to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved International Coma Recovery Scale;Comprehensive non-reactivity assessment tool;Somatosensory evoked potential;Electroencephalogram;Magnetic resonance diffusion tensor imaging;Near-infrared brain functional imaging; | — |
Countries
China
Contacts
Public ContactYan Zhipeng
First Affiliated Hospital of Fujian Medical University
Outcome results
None listed