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

NCT ID: NCT06696690

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-01

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.

Conditions

Median Nerve; Coma; Post Cardiac Arrest Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MNS treatment group

Bundle treatment after cardiac arrest. Meanwhile, 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 300ms, 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 14 days.

Group Type: EXPERIMENTAL

MNS

Intervention Type: DEVICE

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.

Sham stimulation treatment group

Bundle treatment after cardiac arrest. The control 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.

Group Type: PLACEBO_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang Ziren

OTHER

Sponsor Role: lead

Responsible Party

Tang Ziren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Ziren Tang, Prof.

Role: CONTACT

tangziren1970@163.com

+86 010-85231530

Facility Contacts

Le An, M.M.

Role: primary

13910828460@163.com

+86 13910828460

Other Identifiers

2024-6-7-3

Identifier Type: -

Identifier Source: org_study_id