Transcutaneous Vagus Nerve Stimulation for Attention and Memory

NCT06723743 | Recruiting FDA Device

• 1 other identifier: H-56468
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans with traumatic brain injury (TBI) and depression and/or posttraumatic stress disorder (PTSD). The study seeks to answer two main questions:

• 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.

Conditions

Traumatic Brain Injury (TBI) Patients

Keywords

vagus nerve stimulation; attention; brain stimulation; PTSD; depression

Outcome Measures

Primary Outcomes (1)

• Attention and working memory

  Aim 1: To evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on sustained attention and working memory. Attention and memory performance will be assessed using the Gradual Onset Continuous Performance Task (gradCPT), a validated computerized test that measures the ability to sustain attention and respond selectively to relevant stimuli. This cognitive test measures sustained attention and inhibitory control. During the test, subjects view a continuous stream of gradually fading images of cities and mountains on a computer screen. They are instructed to press the space bar when they see a city (target stimulus) and withhold responses when they see a mountain (non-target stimulus). Key performance metrics which collectively assess attention and working memory in this test include mean reaction time (response speed), omission errors (failure to respond to targets), and commission errors (responses to non-targets).

  One day, one visit

Secondary Outcomes (1)

• Heart-rate variability

  One day, one visit

Study Arms (2)

taVNS active stimulation

ACTIVE COMPARATOR

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.

Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI; Device: Soterix Medical Vagus Nerve Stimulation mini-CT

Sham (Placebo) taVNS

SHAM COMPARATOR

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.

Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI; Device: Soterix Medical Vagus Nerve Stimulation mini-CT

Interventions

Transcutaneous vagus nerve stimulation for attention in veterans with TBI OTHER

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.

Sham (Placebo) taVNS; taVNS active stimulation

Soterix Medical Vagus Nerve Stimulation mini-CT DEVICE

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; taVNS active stimulation

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 25-64
• 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

You may not qualify if:

• History of neurological, cardiovascular, or pulmonary disease
• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (2)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 22554199 BACKGROUND

• 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.

  PMID: 35002607 BACKGROUND

• 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.

  PMID: 34806909 BACKGROUND

• 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.

  PMID: 21167932 BACKGROUND

• 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.

  PMID: 36384367 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35137108 BACKGROUND

• 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.

  PMID: 36543841 BACKGROUND

• 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.

  PMID: 35143576 BACKGROUND

• Foley JO, and DuBois FS (1937). Quantitative studies of the vagus nerve in the cat. J Comp Neurol 67, 49-67.

  BACKGROUND

• 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.

  PMID: 26447571 BACKGROUND

• 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.

  PMID: 27896630 BACKGROUND

• 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.

  PMID: 27225070 BACKGROUND

• 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.

  PMID: 30663712 BACKGROUND

• 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.

  PMID: 36937689 BACKGROUND

• 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.

  PMID: 35088719 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Depression

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Central Study Contacts

Lane Witkowski Research Coordinator

CONTACT

206-419-1261; Lane.Witkowski@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)