Restricted accessResearch articleFirst published online 2026-3
A Randomized,Double Blind,Sham-Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS),Compared to a Sham Control for Generalized Anxiety Disorder
Aims and Objectives: It has been hypothesised that vestibular stimulation may have a modulatory effect on anxiety. The aim of this randomised, double blind, sham-controlled trial was to determine the efficacy and safety of a non-invasive electrical vestibular nerve stimulation (VeNS) device as a treatment for anxiety compared to a sham stimulation device. Materials and methods: A total of 60 participants (mean age [SD]: 35.6 [8.1]) with a generalized anxiety disorder assessment (GAD-7) score of ≥10 were randomised to receive either an active VeNS device (n = 34) or a sham control device (n = 26). Both groups were asked to complete 20 stimulation sessions (30 min duration) at a rate of 3-5 sessions per week at a research clinic. The primary outcome was change in GAD-7 score from baseline to the end of study (when each participant finished their 20 stimulation sessions). Secondary outcomes were change in Insomnia Severity Index (ISI), and the Short Form 36 Health Survey (SF-36) scores (8 domains). Results: One participant allocated to the sham group withdrew from the study. The mean (SD) number of weeks it took to complete the 20 stimulation sessions was 5.8. The active group had a statistically greater reduction in GAD-7 score compared to the sham group (−7.4 versus −2.2, P < .001; respectively). A total of 97% (n = 33) of the active group achieved a clinically meaningful reduction (defined as ≥4-point reduction) in GAD-7 from baseline to the follow up visit compared to 24% (n = 6) of the sham group (P < .001). Additionally, the active group showed a significant improvement in ISI (−4.9 versus 2.2, P < .001) and greater improvements on all eight SF36 domains (P < .001) compared with the sham group. There was no device related reported adverse events. Conclusion: Regular non-invasive electrical vestibular nerve stimulation appears to have a clinically meaningful benefit when used as an intervention for Generalized Anxiety Disorder.
JavaidSFHashimIJHashimMJStipESamadMAAl AhbabiA. Epidemiology of anxiety disorders: Global burden and sociodemographic associations. Middle East Current Psychiatry. 2023;30(1):1–11. doi:https://doi.org/10.1186/S43045-023-00315-3/FIGURES/4
4.
GangadharBNKumarCNSadhK, et al.Mental health programme in India: Has the tide really turned?Indian J Med Res. 2023;157(5):387–394. doi:https://doi.org/10.4103/IJMR.IJMR_2217_20
MastFWPreussNHartmannMGrabherrL. Spatial cognition, body representation and affective processes: the role of vestibular information beyond ocular reflexes and control of posture. Front Integr Neurosci. 2014;8(MAY). doi:https://doi.org/10.3389/FNINT.2014.00044
7.
EaggerSLuxonLMDaviesRACoelhoARonMA. Psychiatric morbidity in patients with peripheral vestibular disorder: A clinical and neuro-otological study. J Neurol Neurosurg Psychiatry. 1992;55(5):383–387. doi:https://doi.org/10.1136/JNNP.55.5.383
8.
WinterLKrugerTHCLaurensJ, et al.Vestibular stimulation on a motion-simulator impacts on mood States. Front Psychol. 2012;3(NOV). doi:https://doi.org/10.3389/FPSYG.2012.00499
9.
PreussNHaslerGMastFW. Caloric vestibular stimulation modulates affective control and mood. Brain Stimul. 2014;7(1):133–140. doi:https://doi.org/10.1016/J.BRS.2013.09.003
SaileshKSArchanaRMukkadanJK. Controlled vestibular stimulation: A physiological method of stress relief. J Clin Diagn Res. 2014;8(12):BM01. doi:https://doi.org/10.7860/JCDR/2014/10312.5298
14.
PasquierFDenisePGauthierABessotNQuarckG. Impact of galvanic vestibular stimulation on anxiety level in young adults. Front Syst Neurosci. 2019;13. doi:https://doi.org/10.3389/FNSYS.2019.00014/FULL
TiirikainenKHaravuoriHRantaKKaltiala-HeinoRMarttunenM. Psychometric properties of the 7-item generalized anxiety disorder scale (GAD-7) in a large representative sample of Finnish adolescents. Psychiatry Res. 2019;272:30–35. doi:https://doi.org/10.1016/j.psychres.2018.12.004
ZinkRBucherSFWeissABrandtTDieterichM. Effects of galvanic vestibular stimulation on otolithic and semicircular canal eye movements and perceived vertical. Electroencephalogr Clin Neurophysiol. 1998;107(3):200–205. doi:https://doi.org/10.1016/S0013-4694(98)00056-X
20.
SluydtsMCurthoysIVanspauwenR, et al.Electrical vestibular stimulation in humans: A narrative review. Audiol Neurootol. 2020;25(1-2):6–24. doi:https://doi.org/10.1159/000502407
21.
MacefieldVGJamesC. Superentrainment of muscle sympathetic nerve activity during sinusoidal galvanic vestibular stimulation. J Neurophysiol. 2016;116(6):2689–2694. doi:https://doi.org/10.1152/JN.00036.2016
22.
SapraABhandariPSharmaSChanpuraTLoppL. Using generalized anxiety disorder-2 (GAD-2) and GAD-7 in a primary care setting. Cureus. 2020;12(5). doi:https://doi.org/10.7759/CUREUS.8224
23.
ToussaintAHüsingPGumzA, et al.Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020;265:395–401. doi:https://doi.org/10.1016/J.JAD.2020.01.032
24.
Bauer-StaebCKounaliDZWeltonNJ, et al.Effective dose 50 method as the minimal clinically important difference: Evidence from depression trials. J Clin Epidemiol. 2021;137:200–208. doi:https://doi.org/10.1016/j.jclinepi.2021.04.002
25.
NoijLHaarmanEHashimotoS, et al.Depression, anxiety, and resilience during COVID-19 in Dutch patients with cystic fibrosis or primary ciliary dyskinesia and their caregivers. Pediatr Pulmonol. 2023;58(7):2025–2034. doi:https://doi.org/10.1002/PPUL.26427
26.
LinsLCarvalhoFM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016;4. doi:https://doi.org/10.1177/2050312116671725
27.
MorrissRXydopoulosGCravenMPriceLFordhamR. Clinical effectiveness and cost minimisation model of Alpha-Stim cranial electrotherapy stimulation in treatment seeking patients with moderate to severe generalised anxiety disorder. J Affect Disord. 2019;253:426–437. doi:https://doi.org/10.1016/J.JAD.2019.04.020
MarciniakMDLageMJDunayevichE, et al.The cost of treating anxiety: The medical and demographic correlates that impact total medical costs. Depress Anxiety. 2005;21(4):178–184. doi:https://doi.org/10.1002/DA.20074
30.
OtteC. Cognitive behavioral therapy in anxiety disorders: Current state of the evidence. Dialogues Clin Neurosci. 2011;13(4):413–421. doi:https://doi.org/10.31887/DCNS.2011.13.4/COTTE
31.
VenkatesanSSubramaniamSRajeevPChopraYJoseMNairD. Differential scaling of synaptic molecules within functional zones of an excitatory synapse during homeostatic plasticity. eNeuro. 2020;7(2):1–16. doi:https://doi.org/10.1523/ENEURO.0407-19.2020
32.
LeeCRoundJMHanlonJGHyshkaEDyckJRBEurichDT. Generalized anxiety disorder 7-item (GAD-7) scores in medically authorized Cannabis patients-Ontario and Alberta, Canada. Can J Psychiatry. 2022;67(6):470–480. doi:https://doi.org/10.1177/07067437211043393
33.
LuikAIBostockSChisnallL, et al.Treating depression and anxiety with digital cognitive behavioural therapy for insomnia: A real world NHS evaluation using standardized outcome measures. Behav Cogn Psychother.2017;45(1):91–96. doi:https://doi.org/10.1017/S1352465816000369
34.
Tanguay BernardMMLucMCarrierJD, et al.Patterns of benzodiazepines use in primary care adults with anxiety disorders. Heliyon. 2018;4(7):e00688. doi:https://doi.org/10.1016/J.HELIYON.2018.E00688
35.
Table 7, Summary of recommendations for benzodiazepine use in GAD. Published online July 28, 2014.
36.
MartinJLRSainz-PardoMFurukawaTAMartin-SanchezESeoaneTGalanC. Review: Benzodiazepines in generalized anxiety disorder: Heterogeneity of outcomes based on a systematic review and meta-analysis of clinical trials. J Psychopharmacol.2007;21(7):774–782. doi:https://doi.org/10.1177/0269881107077355
37.
AlbathiMAgrawalY. Vestibular vertigo is associated with abnormal sleep duration. J Vestib Res. 2017;27(2-3):127–135. doi:https://doi.org/10.3233/VES-170617
38.
KrystalADZammitGKWyattJK, et al.The effect of vestibular stimulation in a four-hour sleep phase advance model of transient insomnia. J Clin Sleep Med. 2010;6(4):315–321. doi:https://doi.org/10.5664/jcsm.27871
39.
HorowitzSSBlanchardJMorinLP. Medial vestibular connections with the hypocretin (orexin) system. J Comp Neurol. 2005;487(2):127–146. doi:https://doi.org/10.1002/CNE.20521
40.
IberCDaviesSFMahowaldW. Nocturnal rocking bed therapy: Improvement in sleep fragmentation in patients with respiratory muscle weakness. Sleep. 1989;12(5):405–412. doi:https://doi.org/10.1093/SLEEP/12.5.405
41.
ScottAJWebbTLMartyn-St JamesMRowseGWeichS. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021;60:101556. doi:https://doi.org/10.1016/J.SMRV.2021.101556
42.
KenwoodMMKalinNHBarbasH. The prefrontal cortex, pathological anxiety, and anxiety disorders. Neuropsychopharmacology. 2022;47(1):260–275. doi:https://doi.org/10.1038/S41386-021-01109-Z
43.
MarkiaBKovácsZIPalkovitsM. Projections from the vestibular nuclei to the hypothalamic paraventricular nucleus: Morphological evidence for the existence of a vestibular stress pathway in the rat brain. Brain Struct Funct. 2008;213(1-2):239–245. doi:https://doi.org/10.1007/S00429-008-0172-6
44.
White-TrautRCSchwertzDMcFarlinBKoganJ. Salivary cortisol and behavioral state responses of healthy newborn infants to tactile-only and multisensory interventions. J Obstet Gynecol Neonatal Nurs. 2009;38(1):22–34. doi:https://doi.org/10.1111/J.1552-6909.2008.00307.X
45.
ZouGLiYLiuJ, et al.Altered thalamic connectivity in insomnia disorder during wakefulness and sleep. Hum Brain Mapp. 2021;42(1):259–270. doi:https://doi.org/10.1002/HBM.25221
46.
ChoueiryNSalamounTJabbourHEl OstaNHajjAKhabbazLR. Insomnia and relationship with anxiety in university students: A cross-sectional designed study. PLoS One. 2016;11(2):49643. doi:https://doi.org/10.1371/JOURNAL.PONE.0149643
47.
RajagopalanAJinuKVSaileshKSMishraSReddyUKMukkadanJK. Understanding the links between vestibular and limbic systems regulating emotions. J Nat Sci Biol Med. 2017;8(1):11. doi:https://doi.org/10.4103/0976-9668.198350
48.
HagiwaraKPerchetCFrotMBastujiHGarcia-LarreaL. Cortical modulation of nociception by galvanic vestibular stimulation: A potential clinical tool?Brain Stimul. 2020;13(1):60–68. doi:https://doi.org/10.1016/J.BRS.2019.10.009
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
