Transauricular vagus nerve stimulation to improve heart function after spinal cord injury
The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury
This trial will test whether gentle electrical stimulation of the ear (taVNS) can improve heart autonomic function in adults with chronic cervical spinal cord injury who have had autonomic dysreflexia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07007884 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults with traumatic cervical spinal cord injury at least six months after injury and a history of autonomic dysreflexia, randomizing them to active transauricular vagus nerve stimulation (taVNS) or a sham stimulation. Stimulation is applied at the auricular site to noninvasively target vagal pathways, and cardiac autonomic function will be tracked using heart rate variability and other cardiovascular markers. Key exclusions include pacemakers, pregnancy, coronary artery disease, arrhythmias, treated hypertension, and skin lesions at the application area. The protocol compares repeated taVNS sessions with sham to see if there are measurable improvements in autonomic control.
Who should consider this trial
Good fit: Adults aged 18–60 with traumatic cervical spinal cord injury at least six months old and a documented history of autonomic dysreflexia, who can consent and do not have excluded cardiac conditions, are the best fit.
Not a fit: Patients who are pregnant, have pacemakers or significant coronary disease, documented arrhythmias, treated hypertension, or damaged skin at the ear site are unlikely to benefit or may be excluded for safety.
Why it matters
Potential benefit: If successful, taVNS could improve heart rate variability, reduce autonomic dysreflexia episodes, and lower cardiovascular risk in people with cervical spinal cord injury.
How similar studies have performed: Noninvasive taVNS has produced promising but mixed improvements in autonomic and cardiac measures in other populations, while direct evidence specifically in people with spinal cord injury is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18-60 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: 1. Having a cardiac or neural pacemaker 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
Where this trial is running
Ankara
- SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi — Ankara, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.