RecruitingNot ApplicableNCT07413562

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

Sponsor

Beijing Tiantan Hospital

Enrollment

30 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury Cognitive Dysfunction

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria5

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.

Exclusion Criteria8

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.

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Interventions

DEVICEMedian nerve stimulation

Participants 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.

DRUGSham

The 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.