Transkutánní stimulace nervu vagus pro pozornost a paměť (taVNS)
TRANSKUTÁNNÍ STIMULAČNÍ ÚČINKY UŠNÍHO VAGUSOVÉHO NERVU na POZORNOST a PRACOVNÍ PAMĚŤ: PILOTNÍ STUDIE
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:
- Can active taVNS improve attention and memory compared to sham (placebo) stimulation?
- 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.
Přehled studie
Postavení
Detailní popis
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:
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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.
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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.
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Break:
Participants will have a short break between sessions, during which they can rest or engage in light activities.
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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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Lane Witkowski Research Coordinator
- Telefonní číslo: 206-419-1261
- E-mail: Lane.Witkowski@va.gov
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77030
- Michael E. DeBakey VA Medical Center
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Vrchní vyšetřovatel:
- Ricardo Jorge, MD
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Vrchní vyšetřovatel:
- Principal Investigator
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Kontakt:
- Ricardo Jorge, MD
- Telefonní číslo: 226175 (713) 791-1414
- E-mail: ricardo.jorge@bcm.edu
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Kontakt:
- Lane Witkowski
- Telefonní číslo: 206-419-1261
- E-mail: lane.witkowski@bcm.edu
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Kontakt:
- Audri Villalon
- E-mail: audriv@bcm.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
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 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. |
|
Falešný srovnávač: 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. |
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 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Attention and working memory
Časové okno: One day, one visit
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Heart-rate variability
Časové okno: One day, one visit
|
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. |
One day, one visit
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Trauma a poruchy související se stresem
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Rány a zranění
- Symptomy chování
- Kraniocerebrální trauma
- Trauma, nervový systém
- Poranění mozku
- Stresové poruchy, traumatické
- Chování
- Poranění mozku, traumatické
- Deprese
- Stresové poruchy, posttraumatické
- Vyšetřovací techniky
- Terapeutika
- Radioterapie
- Ozařování celého těla
Další identifikační čísla studie
- H-56468
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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