Coma, Median Nerve, Post Cardiac Arrest Brain Injury
Conditions
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.
Interventions
DEVICEMNS
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.
DEVICESham 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.
Sponsors
Tang Ziren
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZiren Tang, Prof.
Outcome results
None listed