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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNS treatment group | Experimental | Bundle treatment after cardiac arrest. Meanwhile, use the NeuroTracâ„¢ 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNS | Device | The MNS treatment group use the NeuroTracâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziren Tang, Prof. | Contact | +86 010-85231530 | tangziren1970@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | 100020 | China |
All IPD that underlie results in a publication
Starting 6 months after publication
The de-identified survey data will be made available for research purposes by contacting the corresponding authors
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| 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. |
|
| ID | Term |
|---|---|
| D003128 | Coma |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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