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Traumatic Brain Injury (TBI) PatientstaVNSNCT06723743

Transcutaneous Vagus Nerve Stimulation for Attention and Memory

A study testing Transcutaneous vagus nerve stimulation for attention in veterans with TBI and Soterix Medical Vagus Nerve Stimulation mini-CT in people with Traumatic Brain Injury (TBI) Patients, run by Baylor College of Medicine at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 25 to 64 years
Conditions the study is for
Traumatic Brain Injury (TBI) Patients
What is being tested?
Transcutaneous vagus nerve stimulation for attention in veterans with TBI and Soterix Medical Vagus Nerve Stimulation mini-CT
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
Dec 2026to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lane Witkowski Research Coordinator contact

206-419-1261

Lane.Witkowski@va.gov

United States2 sites

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

    Ricardo Jorge, MD, (713) 791-1414 ext. 226175, ricardo.jorge@bcm.edu

    Principal Investigator

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

    Lane Witkowski, 206-419-1261, lane.witkowski@bcm.edu

    Audri Villalon, audriv@bcm.edu

Other trials in United States

About this study

Official title: Transcutaneous Auricular Vagus Nerve Stimulation Effects on Attention and Working Memory: A Pilot Study

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:

  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.
Read more

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.

Read the detailed description

Attention and memory problems are common in veterans with traumatic brain injuries (TBI), particularly when accompanied by depression and/or posttraumatic stress disorder (PTSD). Current treatments for these issues often have limited effectiveness or unwanted side effects. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive technique that uses gentle electrical impulses delivered through electrodes placed on the ear. This stimulation targets the vagus nerve, which plays a key role in regulating brain areas involved in attention and memory. By enhancing the activity of these brain regions, taVNS shows potential as a novel treatment option for improving cognitive functions like attention and memory.

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.

Being tested
Transcutaneous vagus nerve stimulation for attention in veterans with TBI, Soterix Medical Vagus Nerve Stimulation mini-CT
Keywords
vagus nerve stimulation, attention, brain stimulation, PTSD, depression
Medical subject headings
Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous vagus nerve stimulation for attention in veterans with TBIOther

    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-CTDevice

    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.

Study groups in NCT06723743
Study groupRoleWhat they receive
taVNS active stimulationActive comparatorParticipants 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.
Receives: Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI; Device: Soterix Medical Vagus Nerve Stimulation mini-CT
Sham (Placebo) taVNSSham comparatorParticipants 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.
Receives: Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI; Device: Soterix Medical Vagus Nerve Stimulation mini-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: One day, one visit

Secondary outcomes (1)

  1. Heart-rate variability

    Aim 2: To investigate the effects of taVNS on heart rate variability (HRV), an indicator of autonomic nervous system activity. HRV will be measured in milliseconds using a lightweight, wearable chest device capable of capturing continuous heart rate data. Key HRV metrics, including standard deviation of NN intervals (SDNN) and root mean square of successive differences (RMSSD), will be analyzed before, during, and after active and sham taVNS sessions to assess physiological responses to stimulation.

    Measured: One day, one visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study startDec 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06723743
Sponsor's protocol ID
H-56468
Acronym
taVNS
Status last verified
Oct 2026
First submitted
4 Dec 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data (IPD) will not be shared because this is an exploratory, feasibility trial designed to assess the potential effects of transcutaneous auricular vagus nerve stimulation (taVNS). As a pilot study, the primary goal is to evaluate the intervention's feasibility and gather preliminary data, rather than generate findings intended for broader generalization. To protect participant privacy and confidentiality, all data will be reported in aggregate form without identifying individual participants, in accordance with ethical guidelines and institutional policies.

Publications

  • 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.

    PubMed 22554199

  • 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.

    PubMed 35002607

  • 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.

    PubMed 34806909

  • 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.

    PubMed 21167932

  • 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.

    PubMed 36384367

  • 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.

    PubMed 35137108

  • 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.

    PubMed 36543841

  • 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.

    PubMed 35143576

  • 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.

    PubMed 26447571

  • 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.

    PubMed 27896630

  • 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.

    PubMed 27225070

  • 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.

    PubMed 30663712

  • 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.

    PubMed 36937689

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous vagus nerve stimulation for attention in veterans with TBI and Soterix Medical Vagus Nerve Stimulation mini-CT in people with Traumatic Brain Injury (TBI) Patients, run by Baylor College of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lane Witkowski Research Coordinator (206-419-1261, Lane.Witkowski@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attention and working memory (time frame: One day, one visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06723743, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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