Feasibility and Safety of a Single‐Session of Transcutaneous Cervical Magnetic Stimulation, taVNS, and iTBS on Heart Rate Variability, Safety, and Pain Modulation
The autonomic nervous system (ANS) plays a crucial role in maintaining homeostasis, and its dysfunction is linked to numerous clinical conditions, including chronic pain. Neuromodulatory interventions such as transcutaneous auricular vagus nerve stimulation (taVNS), transcutaneous cervical magnetic stimulation (tCMS), and intermittent theta burst stimulation (iTBS) have been investigated for their potential to modulate autonomic responses and pain perception. However, the efficacy and safety of these techniques remain unclear. This study aimed to evaluate the feasibility and safety of a single session of neuromodulatory stimulation in modulating autonomic function and pain processing in healthy individuals. A double-blind, randomized, crossover clinical trial was conducted with 22 healthy participants, each undergoing four intervention sessions (taVNS, tCMS, iTBS, and Sham-taVNS) in randomized order, with a washout period of at least 36 h between sessions. Heart rate variability (HRV) and conditioned pain modulation (CPM) were assessed pre- and post-intervention using a Polar H10 cardiac sensor and a digital pressure algometer. Adverse effects were recorded immediately after each session. No statistically significant differences were observed in HRV or CPM outcomes across active stimulation conditions when compared to Sham. Among the techniques evaluated, tCMS presented the most favorable safety profile, with fewer reported adverse effects relative to iTBS and taVNS. The absence of significant modulation effects suggests that a single session may be insufficient to induce detectable changes in autonomic or pain processing. However, the tolerability and safety of tCMS indicate its potential for future research involving repeated sessions and clinical populations.
Authors
- Thaiany Pedrozo Campos Antunes (ORCID: https://orcid.org/0000-0002-8682-1285)
- Abrahão Fontes Baptista (ORCID: https://orcid.org/0000-0001-7870-3820)
- Pedro Montoya (ORCID: https://orcid.org/0000-0001-8652-948X)
- Yossi Zana (ORCID: https://orcid.org/0000-0003-0539-7492)
- Karina Rabello Casali (ORCID: https://orcid.org/0000-0001-8281-0135)
- Erick Dario León Bueno de Camargo (ORCID: https://orcid.org/0000-0001-6191-0620)
- M Morimoto (ORCID: https://orcid.org/0000-0003-3449-729X)
- Larissa Conceição Dias Lopes (ORCID: https://orcid.org/0000-0002-7648-4879)
- Bruna Ferreira Nonato
- Tiago da Silva Lopes
- Maria Sophia Cantisani
- Gustavo Pinheiro
- Isabela Rocha Fernandes
Institutions
- Federal Institute of São Paulo (BR)
- Universidade Federal do Rio de Janeiro (BR)
- Universidade Municipal de São Caetano do Sul (BR)
- Department of Aerospace Science and Technology (BR)
- Health Research Institute of the Balearic Islands (ES)
- International Neuromodulation Society (US)
- Universidade Federal do ABC (BR)
- Universidade Federal de São Paulo (BR)
Publication Details
- Journal
- European Journal of Neuroscience
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1111/ejn.70370
- Primary Topic
- Vagus Nerve Stimulation Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- European Regional Development Fund
- Agencia Estatal de Investigación