Median nerve stimulation to improve thinking after recent traumatic brain injury
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07413562 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.