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NCT05289817: ESautonomous
Effects of Transcutaneous Electrical Stimulation on the Autonomous Nerve System in Healthy Young People
NA trial testing Transcutaneous Vagus Nerve Stimulation (t-VNS) in Healthy Volunteers in 30 participants. Completed in 29 June 2022.
27 June 2022
Quick facts
| Lead sponsor | Universidade da Coruña |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 22 March 2022 |
| Primary completion | 27 June 2022 |
| Estimated completion | 29 June 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Transcutaneous Vagus Nerve Stimulation (t-VNS)
- Transcutaneous Sympathetic Ganglion Electrical Stimulation (t-SES)
- Sham Transcutaneous vagus nerve stimulation (Sham t-VNS)
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Cardiovascular System — all drugs for Cardiovascular System →
- Autonomic Nervous System — all drugs for Autonomic Nervous System →
Sponsor
Universidade da Coruña
Who can join
Adults 18 to 35, any sex, with Healthy Volunteers or Cardiovascular System. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cardiovascular disease is one of the most important causes of death and disability in the world. An autonomic imbalance is associated to cardiovascular risks and disorders. Electrical stimulation (ES) applied by surface electrodes is a non-invasive therapeutic approach with low side-effects. In the last years, some studies had investigated the effects of ES on the autonomic nervous system and cardiovascular system. However, different intensities, frequencies and electrode locations had been used, which makes difficult to clarify the optimal parameters. The aim of this study is to analyze the effects of ES on autonomic nervous modulation in healthy subjects comparing three different locations of application for ES. Participants will be aleatory assigned to one of three groups for a single-session of 20-minute transcutaneous ES: a) an auricular intermittent ES in an area that is believed to be connected to the vagal nerve (cymba conchae); b) an auricular sham intermittent ES, meaning a real ES but applied on an ear location not connected to the vagal nerve (scapha); and c) an upper back continuous ES (C7-T4), a placement that is thought to be connected to the stellate (sympathetic) ganglion. All the protocols will be stated at a non-painful intensity. After that, the hand grip exercise will be executed. The heart rate variability (HRV) and heart frequency (HR) will be measured in four main times: the baseline, in the final minutes of the ES, after the ES and after finishing the hand grip exercise. Blood pressure will be measured also at all the time points except during the ES due to the possibility of interferences. Adverse effects will be assessed after ES and 48 h later. The study will provide initial knowledge about how different electrical stimulation locations contribute to reduce sympathetic excitation and improve the sympathovagal balance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05289817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05289817 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade da Coruña
- Last refreshed: 1 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05289817.
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