Currently, the treatment of cognitive dysfunction after acute TBI remains a challenge, and novel therapeutic methods are urgently needed. Median nerve stimulation (MNS) is a non-invasive neuromodulation technique and recently has shown positive effects in awaking coma of acute brain injury. It has been shown to improve cognition in healthy volunteers and may be a potential therapeutic approach for cognitive dysfunction in patients with acute TBI. Therefore, the main purpose of the study is to evaluate the feasibility, safety, and preliminary efficacy of MNS for cognitive dysfunction in patients with acute TBI.
Aged 18-64 years.
Admitted within 3 days post-injury with a Glasgow Coma Scale (GCS) score of 9-12 at admission, accompanied by imaging abnormalities.
Presence of cognitive dysfunction assessed within 1-week after injury, with a Mini-Mental State Examination (MMSE) score ≤26.
Pre-injury Clinical Dementia Rating (CDR) score = 0 as reported by family members.
Requirement for emergent neurosurgical intervention during treatment including surgery, intracranial pressure monitoring device placement, or drainage catheter insertion.
Unstable vital signs or hemodynamics, or presence of unstable cardiac, pulmonary, hepatic, renal, or hematopoietic system disorders.
Pre-existing central nervous system conditions causing cognitive decline: traumatic brain injury, intracranial infection, brain tumor, epilepsy, stroke, neurodegenerative diseases, carbon monoxide poisoning, and alcohol abuse.
Inability to complete assessments or examinations due to severe visual or auditory impairment, severe psychiatric or behavioral disorders, MRI contraindications, and MEG intolerance.
Parallel
Median nerve stimulation
DeviceParticipants will receive right median nerve stimulation therapy (right median nerve electrical stimulator, XCH-B1, Jiangxi Nuocheng Electrical Equipment Co., Ltd.). Both frequency of 40 Hz and pulse width of 300 µs are fixed and applied within a 20-s on/40-s off protocol. Stimulation will be administered for 8 hours per day over a 2-week period.
Sham
DrugThe participants in the sham stimulation group will receive no electrical stimulation (0 mA) via an activated stimulator, with all other device settings and procedures identical to those used in the active stimulation group.
Change in global cognitive function assessed by the Mini-Mental State Examination(MMSE)
The MMSE will be used to evaluate global cognitive function. Assessments will be conducted by two trained occupational researchers who are blinded to group allocation and not involved in the intervention.
Global cognitive function (MoCA)
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point screening tool evaluating multiple cognitive domains including attention, memory, language, executive function, and visuospatial ability. Higher scores indicate better cognitive performance, and a score below 26 suggests cognitive impairment.
Verbal fluency
Verbal fluency will be assessed using the Verbal Fluency Test, in which participants are asked to generate as many words as possible within 1 minute. The test evaluates language production and executive control, with higher word counts indicating better performance.
Language function
Language ability will be assessed using the Boston Naming Test, which requires participants to name a series of visually presented objects. Higher scores reflect better confrontation naming ability and language function.
Visuospatial function
Visuospatial ability will be assessed using the Rey-Osterrieth Complex Figure Test (RCFT), which evaluates visuospatial construction and visual memory through figure copying and recall tasks. Higher scores indicate better visuospatial performance.
Feasibility outcomes
Feasibility will be evaluated by enrollment rate, recruitment rate, adherence rate (proportion of completed scheduled stimulation hours), and retention rate (completion of all outcome assessments).
Safety outcomes
Adverse events related to the intervention (e.g., skin pain, uncomfortable cutaneous sensations, dizziness, abnormal blood pressure, or heart rhythm disturbances) will be recorded. Side effects will be monitored using a 10-item Likert-scale questionnaire (score range: 1 = absent to 5 = severe).
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