About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MNS
- Sham stimulation
Treatment groups
Sponsors and collaborators
Tang Ziren
Lead sponsor
Capital Medical University
Sponsor institution