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

StatusNot Yet Recruiting
PhaseNot applicable
SponsorTang Ziren
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Apr 1, 2027 to Dec 1, 2027
    • Start date: Jan 1, 2025 to May 1, 2025
    v3
  2. Minor Study Status, Eligibilityv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
7 trials monitored
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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.
Trial Details
NCT Number NCT06696690
Lead Sponsor Tang Ziren
Conditions
(from sponsor)
Median Nerve, Coma, Post Cardiac Arrest Brain Injury
Related terms Coma
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov