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

NCT06696690 | Not Yet Recruiting DMC

• 1 other identifier: 2024-6-7-3
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with a CPC score of 1-2

  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.

  180 days

Study Arms (2)

MNS treatment group

EXPERIMENTAL

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.

Device: MNS

Sham stimulation treatment group

PLACEBO COMPARATOR

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.

Device: Sham stimulation

Interventions

MNS 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.

MNS treatment group

Sham stimulation 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.

Sham stimulation treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tang Ziren: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ziren Tang, Prof.

CONTACT

+86 010-85231530; tangziren1970@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The de-identified survey data will be made available for research purposes by contacting the corresponding authors

Locations

CN (1)