Status:
COMPLETED
Study of the Effects of the Non-invasive Trigeminal Nerve Stimulation on Ischemic Stroke Patients
Lead Sponsor:
Xidian University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In patients with ischemic stroke, the primary focus revolves around enhancing the neuroprotective and rehabilitative effects of external trigeminal nerve stimulation (eTNS) and elucidating its underly...
Detailed Description
This study conducted a randomized controlled clinical trial with an intention to enroll 60 patients. Patients were randomly assigned in a 1:1 ratio to two groups: 1) External trigeminal nerve stimulat...
Eligibility Criteria
Inclusion
- Age over 18 years;
- Medically diagnosed with acute ischemic stroke;
- Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;
- NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;
- Signed informed consent form;
- Ability and willingness to comply with the study requirements.
Exclusion
- History of ischemic or hemorrhagic stroke within the past 3 months;
- Patients in a comatose state;
- Severe allergic reaction to MR contrast agents or renal impairment, eGFR \<30 ml/min, excluding the use of contrast agents;
- Pregnant or breastfeeding women;
- Any other life-threatening or severe medical condition that may interfere with the completion of the study protocol, including the 3-month follow-up;
- Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain;
- Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;
- Refusal to sign the informed consent form;
- Presence of contraindications related to MRI scanning.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06540417
Start Date
July 25 2024
End Date
December 20 2024
Last Update
July 20 2025
Active Locations (1)
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1
Xidian University
Xi'an, Shaanxi, China