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

Not Applicable

Not yet recruiting

• Conditions: Median Nerve; Coma; Post Cardiac Arrest Brain Injury

• Registration Number: NCT06696690
• Lead Sponsor: Tang Ziren

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-11-17
• Study First Posted: 2024-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age ≥ 18 years old.
2. Hemodynamics remains continuously stable for ≥ 7 days.
3. There is still a lack of purposeful movements after the return of spontaneous circulation following cardiopulmonary resuscitation.
4. Advanced life support is provided within 6 hours after the return of spontaneous circulation (ROSC).

Exclusion Criteria

1. Patients with hemodynamic instability.
2. Pregnant patients.
3. Those who have abnormal anatomical structures on the median nerve conduction pathway and are unable to receive electrical stimulation.
4. Patients with a confirmed history of epilepsy before admission or during hospitalization.
5. Patients with severe arrhythmia or those who have pacemakers implanted.
6. Patients whose family members do not agree to their enrollment in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a CPC score of 1-2	180 days	The primary outcome is the proportion of patients with a score of 1-2 at 180 days after randomization in each group. Favorable: 1 means full recovery or mild disability; 2 means moderate disability but independent in activities of daily living (ADLs). Unfavorable: 3 means severe disability-Dependent in ADLs; 4 means persistent vegetive state; 5 means Death.

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China