Feasibility, Safety, and Preliminary Efficacy of Median Nerve Stimulation for Cognitive Dysfunction in Patients With Acute Traumatic Brain Injury

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury, Cognitive Dysfunction

In brief

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.

Key facts

Study ID

NCT07413562

Run by

Beijing Tiantan Hospital

People needed

30

Starts

2025-02-01

Expected to finish

2026-12-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• Short life expectancy due to critical illnesses.
• Right forearm with extensive skin lesions or scars, right median nerve injury, brachial plexus injury, cervical spinal cord injury, or intolerance to MNS.
• Pregnant or lactating women.
• Participation in other ongoing clinical trials.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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