Median nerve stimulation to improve thinking after recent traumatic brain injury
Official title: Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury (MARS-TBI): Study Protocol for a Pilot Randomized Controlled Trial
Run by Beijing Tiantan Hospital · NCT07413562 · Data updated 2026-11-12
This trial will test whether noninvasive median nerve stimulation can help improve thinking, memory, and attention in adults who have cognitive problems soon after a traumatic brain injury.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07413562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–64 admitted within 3 days of injury with moderate TBI (GCS 9–12), documented imaging abnormalities, early cognitive dysfunction (MMSE ≤26 within one week), pre-injury independence (CDR = 0), and at least six years of education who can cooperate with testing.
✕Probably not a fit
Patients who need emergent neurosurgery, have unstable vital signs or major organ instability, or pre-existing neurological conditions causing cognitive decline are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll adults with acute moderate TBI and early cognitive dysfunction and deliver either active median nerve stimulation or a sham procedure. Treatments are noninvasive and designed to modulate neural activity; cognitive performance will be measured with standard scales and imaging such as MRI and magnetoencephalography. The study focuses on feasibility, safety, and early signals of whether the intervention speeds cognitive recovery compared with sham. Data will inform whether larger trials are warranted.
Why it matters
Potential benefit: If successful, this approach could speed recovery of thinking and reduce long-term cognitive disability after acute TBI.
How similar studies have gone: Small prior work shows MNS can hasten awakening after severe brain injury and improve cognition in healthy volunteers, but its use for acute-TBI cognitive dysfunction is relatively novel with only preliminary evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-64 years. 2. Admitted within 3 days post-injury with a Glasgow Coma Scale (GCS) score of 9-12 at admission, accompanied by imaging abnormalities. 3. Presence of cognitive dysfunction assessed within 1-week after injury, with a Mini-Mental State Examination (MMSE) score ≤26. 4. Pre-injury Clinical Dementia Rating (CDR) score = 0 as reported by family members. 5. With a pre-injury education of ≥6 years, able to comprehend instructions and cooperate in completing scale assessments, magnetic resonance imaging (MRI), and magnetoencephalography (MEG) examinations. Exclusion Criteria: 1. Requirement for emergent neurosurgical intervention during treatment including surgery, intracranial pressure monitoring device placement, or drainage catheter insertion. 2. Unstable vital signs or hemodynamics, or presence of unstable cardiac, pulmonary, hepatic, renal, or hematopoietic system disorders. 3. 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. 4. Inability to complete assessments or examinations due to severe visual or auditory impairment, severe psychiatric or behavioral disorders, MRI contraindications, and MEG intolerance. 5. Short life expectancy due to critical illnesses. 6. Right forearm with extensive skin lesions or scars, right median nerve injury, brachial plexus injury, cervical spinal cord injury, or intolerance to MNS. 7. Pregnant or lactating women. 8. Participation in other ongoing clinical trials.
Where it's running
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Guoyi Gao, MD — Beijing Tiantan Hospital
- Study coordinator: Liang Wu, MD
- Email: wuliang@bjtth.org
- Phone: 18301674233
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.