Effect of Transauricular Vagal Stimulation on Cardiac Function After Spinal Cord Injury
NCT ID: NCT07007884
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-20
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Cervical spinal cord injury - Active taVNS
The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active transaurikular vagal nerve stimülation (taVNS) group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
Active Transauricular Vagus Nerve Stimulation
Active taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left ear cymba choncae with a stimulator. Active taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform. In the sham group, stimulation was applied to the lobulus auriculae of the left ear (which is not innervated by the vagus nerve) using the same current intensity and duration as the active group.
Cervical spinal cord injury - Sham taVNS
The study included 30 traumatic SCI patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
Sham Transauricular Vagus Nerve Stimulation
Sham taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left lobulus auriculae of the left ear (which is not innervated by the vagus nerve) with a stimulator. Sham taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform.
Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNS
The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
Active Transauricular Vagus Nerve Stimulation
Active taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left ear cymba choncae with a stimulator. Active taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform. In the sham group, stimulation was applied to the lobulus auriculae of the left ear (which is not innervated by the vagus nerve) using the same current intensity and duration as the active group.
Interventions
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Active Transauricular Vagus Nerve Stimulation
Active taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left ear cymba choncae with a stimulator. Active taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform. In the sham group, stimulation was applied to the lobulus auriculae of the left ear (which is not innervated by the vagus nerve) using the same current intensity and duration as the active group.
Sham Transauricular Vagus Nerve Stimulation
Sham taVNS application was performed by stimulating a sterile acupuncture needle (0.25x25 mm) placed on the left lobulus auriculae of the left ear (which is not innervated by the vagus nerve) with a stimulator. Sham taVNS group received for 10 days, 30 minutes with a current intensity of 1 mA, pulse width of 200 µs, frequency of 25 Hz and biphasic sinusoidal waveform.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Having a traumatic spinal cord injury
3. Cervical spinal cord injury patients with a history of autonomic dysreflexia
4. At least 6 months after the injury
5. Signing an informed consent form showing consent to participate in the study
Exclusion Criteria
2. Presence of pregnancy
3. Clinical coronary artery disease confirmed by invasive or coronary computed tomographic angiography
4. History of acute coronary syndrome (unstable angina, myocardial infarction)
5. Documented arrhythmia and/or use of antiarrhythmic drugs on ECG
6. Diagnosis of hypertension and use of antihypertensive drugs
7. Damaged skin lesion in the application area
18 Years
60 Years
ALL
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Ayşenur ŞİMŞEK YAĞLIOĞLU
medical doctor
Locations
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SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Ankara, , Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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E2-23-3620
Identifier Type: -
Identifier Source: org_study_id
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