NCT06696690

The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest

The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest: A Multicenter, Prospective, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Tang Ziren · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Median nerve stimulation (MNS), a non-invasive brain stimulation technique, has been widely adopted in clinical arousal therapies and multiple clinical investigations have attested to the efficacy of this technique; nevertheless, evidence concerning the application of MNS in improving the neurological prognosis of patients with return of spontaneous circulation (ROSC) following cardiac arrest (CA) remains scarce. The current study endeavors to assess the safety and efficacy of MNS treatment in enhancing the neurological prognosis of CA patients after ROSC and it is designed as a multicenter, prospective, randomized controlled trial with an estimated sample size of 400 patients. Eligible patients will be randomly allocated in a 1:1 ratio to either receive MNS treatment or sham stimulation treatment for 8 hours per day for 14 consecutive days and the primary outcome measure is the proportion of patients in each group with a Cerebral Performance Category (CPC) score ranging from 1 to 2, 6 months after randomization, which will help to determine the effectiveness of MNS in providing neuroprotection for patients with ROSC after CA.

Conditions

• Median Nerve
• Coma
• Post Cardiac Arrest Brain Injury

Interventions

Type	Name	Description
DEVICE	MNS	The MNS treatment group use the NeuroTrac™ Multi-TENS transcutaneous electrical stimulator to provide an asymmetric biphasic pulse train with a frequency of 35 Hz, an amplitude of 20 mA and a pulse width of 300 ms, which is on for 20 seconds and off for 50 seconds. The treatment lasts for 8 hours per day and the treatment course lasts for one week.
DEVICE	Sham stimulation	The sham stimulation treatment group utilized the same stimulation device and was subjected to a safe yet ineffective stimulation protocol for sham stimulation. The treatment lasts for 8 hours per day and the treatment course lasts for 14 days.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-20
• Last updated: 2025-04-11

Locations

1 site across 1 country: China