Transauricular vagus nerve stimulation to improve heart function after spinal cord injury
Official title: The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury
Run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · NCT07007884 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | March 20, 2024 |
| Main results expected | July 16, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | June 6, 2025 |
| Trial ID | NCT07007884 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Ankara, Turkey (Türkiye) Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Home neuromodulation for bladder control after spinal cord injury
This study tests home-delivered Injectrode tibial nerve stimulation to improve bladder function in people with chronic spinal cord injury.
-
ARC-IM therapy to help restore walking after spinal cord injury
This study will try ARC-IM Therapy (epidural electrical stimulation) in adults with subacute or chronic traumatic spinal cord injury to see if it helps improve walking and other ambulatory functions.
-
Implant to improve walking after spinal cord injury
This study is testing a special device that helps people with partial spinal cord injuries walk better by stimulating their muscles.
-
Evaluating the ATLAS 2030 Exoskeleton for Children with Spinal Cord Injury
This study is testing a robotic exoskeleton to see if it can help children aged 3 to 14 with spinal cord injuries move better and feel healthier during their rehab sessions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.