NCT07413562

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Traumatic brain injury (TBI), a major cause of death and disability, is a significant public health problem in the worldwide. It can cause cognitive dysfunctions including executive function, memory, attention, language and visuospatial function, which seriously affects the patient's quality of life and places a heavy burden on the country and family. Currently, the main therapeutic methods for cognitive impairment include cognitive training, drug therapy, hyperbaric oxygen therapy, and aerobic exercise therapy. They all have been shown to have potentially positive effects on cognitive impairment. However, the improvement in overall cognitive function is inconsistent. Moreover, all the interventions are usually performed during chronic stage of TBI, leading to often delayed and suboptimal therapeutic outcomes. Thus, treatment options for cognitive impairment during the acute stage of TBI remain limited. Recently, noninvasive neuromodulation techniques, including repetitive transcranial magnetic stimulation, transcranial direct current stimulation, transcutaneous auricular vagus nerve stimulation, and median nerve stimulation, were recognized to have promising potentials in improving cognitive function in patients with cognitive impairment caused by stroke, intracerebral hemorrhage, and TBI. Within them, MNS is a simple, inexpensive, and noninvasive neuromodulation technique that has been found to improve recovery from TBI, hasten awakening from coma in our previous study. Furthermore, clinical studies have shown that it can effectively improve cognitive function in healthy individuals and enhance cognitive recovery following stroke. However, whether MNS has the same beneficial effects in those with cognitive dysfunction after TBI is unclear. The investigators designed the present study to assess the feasibility and safety of MNS and the preliminary effects on cognitive dysfunction in patients with acute TBI. The present study details a pilot trial that will be conducted before a large-scale randomized controlled trial.

Conditions

• Traumatic Brain Injury
• Cognitive Dysfunction

Interventions

Type	Name	Description
DEVICE	Median 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.
DRUG	Sham	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China