Transcutaneous Vagus Nerve Stimulation for Attention and Memory
NCT ID: NCT06723743
Last Updated: 2025-10-22
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
2025-11-30
2026-02-28
Brief Summary
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1. Can active taVNS improve attention and memory compared to sham (placebo) stimulation?
2. Does taVNS affect heart rate variability (HRV)?
taVNS delivers a gentle electrical current to the vagus nerve through electrodes placed on the ear, targeting brain areas involved in attention and memory without requiring surgery.
This study uses a crossover design, meaning all participants will experience two sessions: one with active taVNS and one with sham stimulation. The sham session feels similar but does not deliver actual stimulation, allowing researchers to compare the two and understand taVNS's effects on the brain.
In a single visit, participants will:
* Complete eligibility screening (questionnaires and vital signs).
* Undergo two sessions (one active and one sham), randomly assigned.
* Perform attention tasks before and after each session.
* Have their heart rate monitored during the sessions.
The findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.
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Detailed Description
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In this study, researchers aim to determine whether taVNS can enhance attention and memory in veterans with TBI. Participants will complete a single study visit lasting 2.5 to 3 hours. The visit includes two taVNS sessions, one active and one sham (placebo), to compare their effects. Sham stimulation mimics the sensation of taVNS but does not deliver electrical current to the vagus nerve. This design allows researchers to isolate the specific effects of taVNS.
Procedures:
1. Screening (40 minutes):
Participants will begin by completing questionnaires about their medical history, memory concerns, alcohol and substance use, mood, and demographics. Vital signs (heart rate, blood pressure, and temperature) will also be measured to confirm eligibility.
2. Session 1 (approximately 40 minutes):
Participants will complete a computer-based attention task that involves responding to specific visual cues on a screen. This task takes about 10 minutes. taVNS will then be delivered using electrodes placed on the left ear. For this session, participants will either receive active stimulation or sham stimulation, randomly assigned. The stimulation lasts 20 minutes. After the stimulation, participants will repeat the attention task to assess changes in performance.
3. Break:
Participants will have a short break between sessions, during which they can rest or engage in light activities.
4. Session 2 (approximately 40 minutes):
The same sequence of procedures will be repeated, but participants will receive the alternate type of stimulation (active or sham) in this session. The order of active and sham stimulation is randomly assigned, and participants will not know which session is delivered first.
Throughout both sessions, participants' heart rate variability (HRV) will be monitored using a lightweight chest device. HRV provides insights into how the body responds to stimulation and helps evaluate taVNS's physiological effects.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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taVNS active stimulation
Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed on the left ear. A low-level electrical current will be delivered to stimulate the vagus nerve. This stimulation is designed to activate brain areas involved in attention and memory.
Transcutaneous vagus nerve stimulation for attention in veterans with TBI
taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.
Soterix Medical Vagus Nerve Stimulation mini-CT
Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.
Sham (Placebo) taVNS
Participants will undergo sham stimulation, where electrodes are placed on the left ear to mimic the experience of active taVNS. However, no electrical current will be delivered to the vagus nerve. This sham condition enables a direct comparison with active taVNS, ensuring that any observed changes in working memory and attention can be attributed to the taVNS intervention.
Transcutaneous vagus nerve stimulation for attention in veterans with TBI
taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.
Soterix Medical Vagus Nerve Stimulation mini-CT
Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.
Interventions
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Transcutaneous vagus nerve stimulation for attention in veterans with TBI
taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.
Soterix Medical Vagus Nerve Stimulation mini-CT
Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.
Eligibility Criteria
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Inclusion Criteria
* Right-handedness
* Veterans with a history of deployment to Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND) or other post 9/11 war on terrorism
* History of PTSD and/or depression
* Military related mild traumatic brain injury
* If taking psychotropic medication, demonstrate stability for 3 months
* If taking stimulants, washout period of 12 hours
Exclusion Criteria
* Cardiac arrhythmia (all types)
* Active suicidal ideation
* Visible wounds on skin of the left ear
* Medical implants such as cardiac defibrillators, pacemakers, or deep brain stimulators
* Pregnancy
* Completed taVNS in the past 4 weeks
* Current substance use disorder (exception: mild cannabis use disorder allowed)
* Current moderate or severe alcohol use disorder
* Major cognitive disorder
25 Years
64 Years
ALL
No
Sponsors
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Michael E. DeBakey VA Medical Center
FED
Baylor College of Medicine
OTHER
Responsible Party
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Ricardo Jorge, MD
Professor
Locations
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Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Stefan H, Kreiselmeyer G, Kerling F, Kurzbuch K, Rauch C, Heers M, Kasper BS, Hammen T, Rzonsa M, Pauli E, Ellrich J, Graf W, Hopfengartner R. Transcutaneous vagus nerve stimulation (t-VNS) in pharmacoresistant epilepsies: a proof of concept trial. Epilepsia. 2012 Jul;53(7):e115-8. doi: 10.1111/j.1528-1167.2012.03492.x. Epub 2012 May 3.
Sun JB, Cheng C, Tian QQ, Yuan H, Yang XJ, Deng H, Guo XY, Cui YP, Zhang MK, Yin ZX, Wang C, Qin W. Transcutaneous Auricular Vagus Nerve Stimulation Improves Spatial Working Memory in Healthy Young Adults. Front Neurosci. 2021 Dec 23;15:790793. doi: 10.3389/fnins.2021.790793. eCollection 2021.
Schein J, Adler LA, Childress A, Gagnon-Sanschagrin P, Davidson M, Kinkead F, Cloutier M, Guerin A, Lefebvre P. Economic burden of attention-deficit/hyperactivity disorder among adults in the United States: a societal perspective. J Manag Care Spec Pharm. 2022 Feb;28(2):168-179. doi: 10.18553/jmcp.2021.21290. Epub 2021 Nov 22.
Ruffoli R, Giorgi FS, Pizzanelli C, Murri L, Paparelli A, Fornai F. The chemical neuroanatomy of vagus nerve stimulation. J Chem Neuroanat. 2011 Dec;42(4):288-96. doi: 10.1016/j.jchemneu.2010.12.002. Epub 2010 Dec 16.
Perugi G, De Rosa U, Barbuti M. What value do norepinephrine/dopamine dual reuptake inhibitors have to the current treatment of adult attention deficit hyperactivity disorder (ADHD) treatment armamentarium? Expert Opin Pharmacother. 2022 Dec;23(18):1975-1978. doi: 10.1080/14656566.2022.2148830. Epub 2022 Nov 16. No abstract available.
Nasiri, E., Khalilzad, M., Hakimzadeh, Z. et al. A comprehensive review of attention tests: can we assess what we exactly do not understand?. Egypt J Neurol Psychiatry Neurosurg 59, 26 (2023). https://doi.org/10.1186/s41983-023-00628-4
Konjusha A, Colzato L, Muckschel M, Beste C. Auricular Transcutaneous Vagus Nerve Stimulation Diminishes Alpha-Band-Related Inhibitory Gating Processes During Conflict Monitoring in Frontal Cortices. Int J Neuropsychopharmacol. 2022 Jun 21;25(6):457-467. doi: 10.1093/ijnp/pyac013.
Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
Geng D, Liu X, Wang Y, Wang J. The effect of transcutaneous auricular vagus nerve stimulation on HRV in healthy young people. PLoS One. 2022 Feb 10;17(2):e0263833. doi: 10.1371/journal.pone.0263833. eCollection 2022.
Foley JO, and DuBois FS (1937). Quantitative studies of the vagus nerve in the cat. J Comp Neurol 67, 49-67.
Eriksson J, Vogel EK, Lansner A, Bergstrom F, Nyberg L. Neurocognitive Architecture of Working Memory. Neuron. 2015 Oct 7;88(1):33-46. doi: 10.1016/j.neuron.2015.09.020.
Cowan N. The many faces of working memory and short-term storage. Psychon Bull Rev. 2017 Aug;24(4):1158-1170. doi: 10.3758/s13423-016-1191-6.
Constantinidis C, Klingberg T. The neuroscience of working memory capacity and training. Nat Rev Neurosci. 2016 Jul;17(7):438-49. doi: 10.1038/nrn.2016.43. Epub 2016 May 26.
Badran BW, Yu AB, Adair D, Mappin G, DeVries WH, Jenkins DD, George MS, Bikson M. Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. J Vis Exp. 2019 Jan 7;(143):10.3791/58984. doi: 10.3791/58984.
Arakaki X, Arechavala RJ, Choy EH, Bautista J, Bliss B, Molloy C, Wu DA, Shimojo S, Jiang Y, Kleinman MT, Kloner RA. The connection between heart rate variability (HRV), neurological health, and cognition: A literature review. Front Neurosci. 2023 Mar 1;17:1055445. doi: 10.3389/fnins.2023.1055445. eCollection 2023.
Aniwattanapong D, List JJ, Ramakrishnan N, Bhatti GS, Jorge R. Effect of Vagus Nerve Stimulation on Attention and Working Memory in Neuropsychiatric Disorders: A Systematic Review. Neuromodulation. 2022 Apr;25(3):343-355. doi: 10.1016/j.neurom.2021.11.009. Epub 2022 Jan 26.
Other Identifiers
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H-56468
Identifier Type: -
Identifier Source: org_study_id
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