Heart rate variability, the vagus and calm.
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226 to 250 of 1,007Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial.
Background: Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients' self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity le…
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Rong P, Liu J, Wang L, Liu R, Fang J, Zhao J, Zhao Y, Wang H, Vangel M, Sun S, Ben H, Park J, Li S, Meng H, Zhu B, Kong J (2016)clinical trialMEDLINE-indexed journal, not yet read by usJournal of affective disorders210 citations Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: A nonrandomized controlled pilot study.
Background: Depression presents a significant burden to both patients and society. One treatment that has emerged is vagus nerve stimulation (VNS), an FDA-approved physical treatment for depressive disorders. However, the application of this intervention has been limited by the involvement of surgery and potential side effects. The aim of this study is to explore the effectiveness of stimulating the superficial branches of the vagus nerve as a solo treatment for MDD.
Methods: This is a nonrandomized, controlled study. The first cohort of patients (n=91) only received transcutaneous auricular VNS (taVNS) for 12 weeks. In the second cohort (n=69), patients first received 4 weeks of sham taVNS followed by 8 weeks of taVNS. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary outcome measurement was the 24-item Hamilton De…
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CNS BOLD fMRI effects of sham-controlled transcutaneous electrical nerve stimulation in the left outer auditory canal - a pilot study.
Background: It has recently been shown that electrical stimulation of sensory afferents within the outer auditory canal may facilitate a transcutaneous form of central nervous system stimulation. Functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) effects in limbic and temporal structures have been detected in two independent studies. In the present study, we investigated BOLD fMRI effects in response to transcutaneous electrical stimulation of two different zones in the left outer auditory canal. It is hypothesized that different central nervous system (CNS) activation patterns might help to localize and specifically stimulate auricular cutaneous vagal afferents.
Methodology: 16 healthy subjects aged between 20 and 37 years were divided into two groups. 8 subjects were stimulated in the anterior wall, the other 8 persons received transcutaneous vagus ne…
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A Single Session of Heart Rate Variability Biofeedback Produced Greater Increases in Heart Rate Variability Than Autogenic Training.
Heart rate variability biofeedback (HRV-BF) has been confirmed to increase heart rate variability (HRV) and cardiac outflows by baroreflex in healthy populations and clinical patients. Autogenic training (AT) is common used in the psychological intervention. This study integrates a single-session of HRV-BF and AT into a high-technology mobile application (app), and examines the effects on HRV indices, breathing rates, and subjective relaxation scores. Healthy college students were recruited and assigned to the single-session HRV-BF group or AT group. Participants in the HRV-BF group received HRV-BF combined with paced breathing training, which gradually stepped down their breathing rates from 12, to 8, to 6 breaths/per min; and received feedback of HRV indices from the app. Participants in the AT group received autogenic training and feedback of heart rate from the app. A chest belt Zeph…
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Efficacy of Paced Breathing at the Low-frequency Peak on Heart Rate Variability and Baroreflex Sensitivity.
We developed a simple method for identifying resonance frequency by focusing on the spectral peak of the low-frequency (LF) component of heart rate variability (HRV) and examined the hypothesis that paced breathing at an accurate resonance frequency increases HRV and baroreflex sensitivity (BRS). We assessed a peak frequency of the LF component of the resting HRV by using power spectral analysis under respiratory control at 0.25 Hz, and a resonance frequency, which was evaluated by using the standard breathing maneuver (Lehrer 2007). We examined the effects of paced breathing at the peak frequency of the LF component (Spectral condition) and paced breathing at the resonance frequency as determined by the standard breathing maneuver (Standard condition) on HRV and BRS in 28 healthy college students and young adults. Electrocardiogram, respiration, and noninvasive continuous blood pressure…
matched on Autonomic Nervous System (mesh), Heart Rate (mesh), Baroreflex (mesh), Respiratory Rate (mesh), heart rate variability (text), Electrocardiography (mesh)
Adverse childhood experiences (ACEs) relate to blunted cardiovascular and cortisol reactivity to acute laboratory stress: A systematic review and meta-analysis.
Adverse childhood experiences (ACEs) are associated with poor future mental and physical health. Altered biological reactivity to mental stress may be a possible mechanism linking ACEs to poor health. However, it is not clear if ACEs relate to blunted or exaggerated stress reactivity. This meta-analysis aimed to determine whether exposure to ACEs is associated with cardiovascular and cortisol stress reactivity. A systematic review yielded 37 sources. Random-effects modelling tested the aggregate effects of 83 studies of the association between ACEs and stress reactivity. Exposure to ACEs was associated with relatively blunted cardiovascular and cortisol stress reactivity. Effect sizes did not vary as a function of sample sex or reactivity measure (e.g., heart rate, blood pressure, or cortisol). Meta-regression revealed preliminary evidence of greater blunting in samples of a younger age …
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Systematic review and meta-analysis of the relationship between the heartbeat-evoked potential and interoception.
The Heartbeat Evoked Potential (HEP) has been proposed as a neurophysiological marker of interoceptive processing. Despite its use to validate interoceptive measures and to assess interoceptive functioning in clinical groups, the empirical evidence for a relationship between HEP amplitude and interoceptive processing, including measures of such processing, is scattered across several studies with varied designs. The aim of this systematic review and meta-analysis was to examine the body of HEP-interoception research, and consider the associations the HEP shows with various direct and indirect measures of interoception, and how it is affected by manipulations of interoceptive processing. Specifically, we assessed the effect on HEP amplitude of manipulating attention to the heartbeat; manipulating participants' arousal; the association between the HEP and behavioural measures of cardiac in…
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Effects of music in exercise and sport: A meta-analytic review.
Regular physical activity has multifarious benefits for physical and mental health, and music has been found to exert positive effects on physical activity. Summative literature reviews and conceptual models have hypothesized potential benefits and salient mechanisms associated with music listening in exercise and sport contexts, although no large-scale objective summary of the literature has been conducted. A multilevel meta-analysis of 139 studies was used to quantify the effects of music listening in exercise and sport domains. In total, 598 effect sizes from four categories of potential benefits (i.e., psychological responses, physiological responses, psychophysical responses, and performance outcomes) were calculated based on 3,599 participants. Music was associated with significant beneficial effects on affective valence (g = 0.48, CI [0.39, 0.56]), physical performance (g = 0.31, …
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Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis.
Meditation is a popular form of stress management, argued to mediate stress reactivity. However, many studies in this field commonly fail to include an active control group. Given the frequency with which people are selecting meditation as a form of self-management, it is important to validate if the practice is effective in mediating stress-reactivity using well-controlled studies. Thus, we aimed to conduct a meta-analysis investigating the neurobiological effects of meditation, including focused attention, open monitoring and automatic self-transcending subtypes, compared to an active control, on markers of stress. In the current meta-analysis and systematic review, we included randomised controlled trials comparing meditation interventions compared to an active control on physiological markers of stress. Studied outcomes include cortisol, blood pressure, heart-rate, lipids and periphe…
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Schulz SM (2016)meta-analysisMEDLINE-indexed journal, not yet read by usPhilosophical transactions of the Royal Society of London. Series B, Biological sciences149 citations Neural correlates of heart-focused interoception: a functional magnetic resonance imaging meta-analysis.
Interoception is the ability to perceive one's internal body state including visceral sensations. Heart-focused interoception has received particular attention, in part due to a readily available task for behavioural assessment, but also due to accumulating evidence for a significant role in emotional experience, decision-making and clinical disorders such as anxiety and depression. Improved understanding of the underlying neural correlates is important to promote development of anatomical-functional models and suitable intervention strategies. In the present meta-analysis, nine studies reporting neural activity associated with interoceptive attentiveness (i.e. focused attention to a particular interoceptive signal for a given time interval) to one's heartbeat were submitted to a multilevel kernel density analysis. The findings corroborated an extended network associated with heart-focus…
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Effects of stress on decisions under uncertainty: A meta-analysis.
[Correction Notice: An Erratum for this article was reported in Vol 142(9) of Psychological Bulletin (see record 2016-39486-001). It should have been reported that the inverted u-shaped relationship between cortisol stress responses and decision-making performance was only observed in female, but not in male participants as suggested by the study by van den Bos, Harteveld, and Stoop (2009). Corrected versions of the affected sentences are provided.] The purpose of the present meta-analysis was to quantify the effects that stress has on decisions made under uncertainty. We hypothesized that stress increases reward seeking and risk taking through alterations of dopamine firing rates and reduces executive control by hindering optimal prefrontal cortex functioning. In certain decision situations, increased reward seeking and risk taking is dysfunctional, whereas in others, this is not the ca…
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Hanson S, Jones A (2015)meta-analysisMEDLINE-indexed journal, not yet read by usBritish journal of sports medicine224 citations Is there evidence that walking groups have health benefits? A systematic review and meta-analysis.
Objective: To assess the health benefits of outdoor walking groups.
Design: Systematic review and meta-analysis of walking group interventions examining differences in commonly used physiological, psychological and well-being outcomes between baseline and intervention end.
Data sources: Seven electronic databases, clinical trial registers, grey literature and reference lists in English language up to November 2013.
Eligibility criteria: Adults, group walking outdoors with outcomes directly attributable to the walking intervention.
Results: Forty-two studies were identified involving 1843 participants. There is evidence that walking groups have wide-ranging health benefits. Meta-analysis showed statistically significant reductions in mean difference for systolic blood pressure -3.72 mm Hg (-5.28 to -2.17) and diastolic blood pressure -3.14 mm Hg (-4.15 to -2.13); resting heart rate -2.88 …
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Mick E, McManus DD, Goldberg RJ (2013)meta-analysisMEDLINE-indexed journal, not yet read by usEuropean neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology97 citations Meta-analysis of increased heart rate and blood pressure associated with CNS stimulant treatment of ADHD in adults.
Compared to children, adults with ADHD are at greater risk for developing adverse cardiovascular related outcomes and, if treated, may be likely to carry a greater burden of exposure to stimulant medications. The goal of this report is to critically review the available literature relevant to the cardiovascular safety of CNS stimulants for adult ADHD (aADHD). Twenty potential clinical trials of a CNS stimulant for aADHD have been published between 1979 and 2012. Of these, ten presented sufficient data to estimate the relative change in various cardiovascular parameters associated with ADHD treatment modalities. These trials were predominantly focused on long-acting stimulant preparations for acute symptom reduction (median duration=6 weeks, range: 4-24 weeks) and enrolled relatively young subjects (median age=36 years, range: 22-40). Using random effects meta-analysis, we found that subj…
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Effect of fish oil on heart rate in humans: a meta-analysis of randomized controlled trials.
Background: The effect of fish oil on heart rate (HR), a major risk factor for sudden death, is not well established. We calculated this effect in a meta-analysis of randomized, double-blind, placebo-controlled trials in humans.
Methods and results: Randomized trials of fish oil that evaluated HR were identified through MEDLINE (1966 through January 2005), hand-searching of references, and contact with investigators for unpublished results. Two investigators independently extracted trial data. A pooled estimate was calculated from random-effects meta-analysis. Predefined stratified meta-analyses and meta-regression were used to explore potential heterogeneity. Of 197 identified articles, 30 met inclusion criteria. Evidence for publication bias was not present. In the overall pooled estimate, fish oil decreased HR by 1.6 bpm (95% CI, 0.6 to 2.5; P=0.002) compared with placebo. Between-tri…
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A systematic review of parent-child synchrony: It is more than skin deep.
This manuscript provides a critical review of the literature on parent-child physiological synchrony-the matching of biological states between parents and children. All eligible studies found some evidence of physiological synchrony, though the magnitude and direction of synchrony varied according to methodological factors, including the physiological system examined (i.e., parasympathetic or sympathetic nervous system activity, adrenocortical functioning) and the statistical approach used (e.g., multilevel modeling, correlation). The review underscores the need to consider the context in which physiological synchrony occurs (e.g., family risk) to best understand its significance. Furthermore, the review delineates vital avenues for future research, including the need to assess synchrony across multiple physiological systems and the importance of documenting continuity/change in physiolo…
matched on Parasympathetic Nervous System (mesh), Sympathetic Nervous System (mesh)
The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy.
Objective: We evaluated the efficacy and safety of deep brain anterior thalamus stimulation after 7 and 10 years, and report the incidence of sudden unexpected death in epilepsy (SUDEP) and overall mortality in adults in the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTÉ) study.
Methods: After the 3-month blinded and 9-month unblinded phases, subjects continued to be assessed during long-term follow-up (LTFU) and later a continued therapy access phase (CAP), to further characterize adverse events and the incidence of SUDEP. Stimulus parameter and medication changes were allowed.
Results: One hundred ten implanted subjects accumulated a total of 938 device-years of experience (69 subjects during the LTFU phase and 61 subjects in the CAP phase). Prior to study closure, 57 active subjects continued therapy at 14 study centers, with follow-up of at least 10 (maximum …
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Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ (2021)randomised controlled trialMEDLINE-indexed journal, not yet read by usLancet (London, England)397 citations Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial.
Background: Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke.
Methods: In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer…
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Goadsby PJ, de Coo IF, Silver N, Tyagi A, Ahmed F, Gaul C, Jensen RH, Diener HC, Solbach K, Straube A, Liebler E, Marin JC, Ferrari MD, ACT2 Study Group (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usCephalalgia : an international journal of headache129 citations Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.
Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superio…
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Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P, PRESTO Study Group (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usNeurology178 citations Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.
Objective: To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.
Methods: A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes.
Results: nVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%; p = 0.012) and 60 minutes (21.0% vs 10.0%; p = 0.023) but not at 120 minutes (30.4% vs 19.7%; p = 0.067; primary endpoint; logistic regression) after the first treated attack. A post hoc repeated-measures test provided further insight into the therapeutic benefit of nVNS through 30, 60, and 120 minutes (odd…
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Tyler R, Cacace A, Stocking C, Tarver B, Engineer N, Martin J, Deshpande A, Stecker N, Pereira M, Kilgard M, Burress C, Pierce D, Rennaker R, Vanneste S (2017)randomised controlled trialMEDLINE-indexed journal, not yet read by usScientific reports126 citations Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans.
The aim of the pilot study was to evaluate the effect of Vagus Nerve Stimulation (VNS) paired with sounds in chronic tinnitus patients. All participants were implanted and randomized to a paired VNS (n = 16) or control (n = 14) group. After 6 weeks of home therapy, all participants received paired VNS. The device was used on 96% of days with good compliance. After 6 weeks, the paired VNS group improved on the Tinnitus Handicap Inventory (THI) (p = 0.0012) compared to controls (p = 0.1561). The between-group difference was 10.3% (p = 0.3393). Fifty percent of the participants in the paired VNS group showed clinically meaningful improvements compared to 28% in controls. At one year, 50% of participants had a clinically meaningful response. The therapy had greater benefits for participants with tonal and non-blast induced tinnitus at the end of 6 (24.3% vs. 2%, p = 0.05) and 12 weeks (34% v…
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Silberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, Liebler EJ, Rubenstein Engel E, Tepper SJ, ACT1 Study Group (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usHeadache178 citations Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.
Objective: To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.
Background: Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.
Methods: One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.
Resu…
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Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial.
Objectives: The purpose of this study was to test the transcutaneous noninvasive vagus nerve stimulator (nVNS) (gammaCore©) device to determine if it modulates the peripheral immune system, as has been previously published for implanted vagus nerve stimulators.
Materials and methods: A total of 20 healthy males and females were randomized to receive either nVNS or sham stimulation (SST). All subjects underwent an initial blood draw at 8:00 am, followed by stimulation with nVNS or SST at 8:30 am. Stimulation was repeated at 12:00 pm and 6:00 pm. Additional blood samples were withdrawn 90 min and 24 hour after the first stimulation session. After samples were cultured using the Myriad RBM TruCulture (Austin, TX) system (WBCx), levels of cytokines and chemokines were measured by the Luminex assay and statistical analyses within and between groups were performed using the Wilcoxon Signed Ran…
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Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR, EVENT Study Group (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usNeurology162 citations Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.
Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.
Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use.
Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events wer…
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Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E (2014)randomised controlled trialMEDLINE-indexed journal, not yet read by usEpilepsia131 citations The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial.
Objective: To evaluate whether vagus nerve stimulation (VNS) as adjunct to best medical practice (VNS + BMP) is superior to BMP alone in improving long-term health-related quality of life (HRQoL).
Methods: PuLsE (Open Prospective Randomized Long-term Effectiveness) was a prospective, randomized, parallel-group, open-label, and long-term effectiveness study (conducted at 28 sites in Europe and Canada). Adults with pharmacoresistant focal seizures (n = 112) received VNS + BMP or BMP (1:1 ratio). Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects. Primary endpoint was mean change from baseline HRQoL (using Quality of Life in Epilepsy Inventory-89 total score; QOLIE-89). Secondary endpoints included changes in seizure frequency, responder rate (≥50% decrease in seizure frequency), Centre for Epidemiologic Stud…
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Aaronson ST, Carpenter LL, Conway CR, Reimherr FW, Lisanby SH, Schwartz TL, Moreno FA, Dunner DL, Lesem MD, Thompson PM, Husain M, Vine CJ, Banov MD, Bernstein LP, Lehman RB, Brannon GE, Keepers GA, O'Reardon JP, Rudolph RL, Bunker M (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usBrain stimulation112 citations Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: acute and chronic effects.
Background: Major depressive disorder is a prevalent, disabling, and often chronic or recurrent psychiatric condition. About 35% of patients fail to respond to conventional treatment approaches and are considered to have treatment-resistant depression (TRD).
Objective: We compared the safety and effectiveness of different stimulation levels of adjunctive vagus nerve stimulation (VNS) therapy for the treatment of TRD.
Methods: In a multicenter, double blind study, 331 patients with TRD were randomized to one of three dose groups: LOW (0.25 mA current, 130 μs pulse width), MEDIUM (0.5-1.0 mA, 250 μs), or HIGH (1.25-1.5 mA, 250 μs). A highly treatment-resistant population (>97% had failed to respond to ≥6 previous treatments) was enrolled. Response and adverse effects were assessed for 22 weeks (end of acute phase), after which output current could be increased, if clinically warranted. Ass…
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