Not reported stays not reported
A missing parameter is shown as “Not reported”. It is not treated as zero, estimated from another paper or filled from a typical protocol.
VNS PROTOCOL DATABASE
Study protocols, side by side.
Explore the stimulation methods and protocol parameters reported across a source-reviewed set of auricular, cervical and implanted vagus nerve stimulation studies.
This database records what individual sources reported. It does not rank devices, infer missing parameters or transfer a research protocol into a product recommendation.
Source-reviewed protocols
16
Auricular
8
Cervical
4
Implanted
4
HOW TO READ THIS DATABASE
Reported data, with the gaps left visible.
Primary sources stay attached
Every record keeps its primary-source link, citation and available PMID or DOI so the underlying paper remains one click away.
Methods are not interchangeable
Auricular, cervical and implanted protocols are kept visibly distinct. A protocol from one method should not be assumed to apply to another.
No quality ranking
Database order is not a score of study quality, device quality or clinical usefulness. Use study design and source context when interpreting a row.
CURRENT VIEW
16 protocols
“Not reported” is preserved as a data state. Missing parameters are never inferred.
AuricularProtocol 01
Frangos E, Ellrich J, Komisaruk BR. Non-invasive access to the vagus nerve central projections via electrical stimulation of the external ear: fMRI evidence in humans. Brain Stimul. 2015;8(3):624-636.
Population
healthy adults
Stimulation site
left cymba conchae
Frequency
25 Hz
Session duration
7 min
View reported protocol fields
- Study type
- within-subject fMRI control comparison
- Population
- healthy adults
- Sample size
- 12
- Device
- Cerbomed NEMOS
- Stimulation site
- left cymba conchae
- Laterality
- left
- Contact system
- adjustable earpiece with two hemispheric titanium electrodes
- Frequency
- 25 Hz
- Pulse width
- 250 μs
- Waveform
- Not reported
- Intensity
- individualized below noxious pricking; mean active intensity 0.43 mA
- Duty cycle
- continuous during active stimulation period
- Session duration
- 7 min
- Schedule
- single-session experimental stimulation during fMRI
- Comparator
- left earlobe electrical stimulation
- Outcome domains
- fMRI BOLD / central target engagement
- Protocol notes
- Field-level auricular VNS protocol row. It is not evidence for Neuvago or any other unstudied commercial product.
- Verified date
- 2026-09-27
AuricularProtocol 02
Badran BW, Mithoefer OJ, Summer CE, et al. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018;11(4):699-708.
Population
healthy adults
Stimulation site
inner side of the left tragus
Frequency
1 Hz, 10 Hz, 25 Hz
Session duration
60 s per parameter block
View reported protocol fields
- Study type
- two-visit controlled crossover exploratory trial
- Population
- healthy adults
- Sample size
- 15
- Device
- Digitimer DS7A constant-current stimulator with custom-built ear electrodes
- Stimulation site
- inner side of the left tragus
- Laterality
- left
- Contact system
- custom 1 cm stimulation-surface electrodes with Ten20 conductive paste; anode in ear canal and cathode on tragus surface
- Frequency
- 1 Hz, 10 Hz, 25 Hz
- Pulse width
- 100 μs, 200 μs, 500 μs
- Waveform
- Not reported
- Intensity
- 200% of individual perceptual threshold, determined separately by pulse width and stimulation site
- Duty cycle
- Not reported
- Session duration
- 60 s per parameter block
- Schedule
- two 1-hour visits; nine pulse-width/frequency combinations per visit
- Comparator
- left earlobe stimulation with identical parameter conditions
- Outcome domains
- heart rate, safety/tolerability
- Protocol notes
- Parameter-sweep row preserves all tested values. It must not be collapsed to one recommended setting or converted into a product ranking.
- Verified date
- 2026-09-27
CervicalProtocol 03
Gurel NZ, Wittbrodt MT, Jung H, et al. Transcutaneous cervical vagal nerve stimulation reduces sympathetic responses to stress in posttraumatic stress disorder: a double-blind, randomized, sham controlled trial. Neurobiol Stress. 2020;13:100264.
Population
adults with PTSD
Stimulation site
left neck over the carotid/vagal projection
Frequency
25 Hz
Session duration
120 s per administration
View reported protocol fields
- Study type
- double-blind randomized sham-controlled trial
- Population
- adults with PTSD
- Sample size
- 25
- Device
- gammaCore (electroCore)
- Stimulation site
- left neck over the carotid/vagal projection
- Laterality
- left
- Contact system
- collar electrodes with conductive electrode gel
- Frequency
- 25 Hz
- Pulse width
- Not reported
- Waveform
- five 5 kHz sine-wave cycles in a 1 ms burst, repeated at 25 Hz
- Intensity
- 0-30 V peak; increased to the maximum tolerable level without pain
- Duty cycle
- Not reported
- Session duration
- 120 s per administration
- Schedule
- multiple administrations across a three-day stress protocol
- Comparator
- sham gammaCore waveform
- Outcome domains
- autonomic physiology, cardiovascular/vascular stress response
- Protocol notes
- A 1 ms sinusoidal burst is not converted into a conventional rectangular pulse-width value; pulse_width_us therefore remains NR.
- Verified date
- 2026-09-27
ImplantedProtocol 04
Pardo JV, Sheikh SA, Schwindt GC, et al. Chronic vagus nerve stimulation for treatment-resistant depression decreases resting ventromedial prefrontal glucose metabolism. Neuroimage. 2008;42(2):879-889.
Population
severely treatment-resistant depressed outpatients
Stimulation site
left cervical vagus nerve
Frequency
20 Hz
Session duration
Not reported
View reported protocol fields
- Study type
- longitudinal neuroimaging study embedded in an implanted-VNS depression trial
- Population
- severely treatment-resistant depressed outpatients
- Sample size
- 8
- Device
- Not reported
- Stimulation site
- left cervical vagus nerve
- Laterality
- left
- Contact system
- Not reported
- Frequency
- 20 Hz
- Pulse width
- 250 μs, 500 μs
- Waveform
- Not reported
- Intensity
- 0.5-1.5 mA across participants at 1 year; mean 1.0 mA
- Duty cycle
- 30 s on / 5 min off
- Session duration
- Not reported
- Schedule
- chronic stimulation for approximately one year
- Comparator
- within-subject baseline and no-stimulation control period for a subset during the initial blinded phase
- Outcome domains
- resting cerebral glucose metabolism, depression symptom score
- Protocol notes
- Implanted-VNS research context. Exact lead/generator model, waveform shape and single-session duration are left NR rather than inferred.
- Verified date
- 2026-09-27
AuricularProtocol 05
Badran BW, Dowdle LT, Mithoefer OJ, et al. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018;11(3):492-500.
Population
healthy adults aged 18-45 years
Stimulation site
left tragus
Frequency
25 Hz
Session duration
6 min per concurrent taVNS/fMRI run
View reported protocol fields
- Study type
- two-visit single-blind crossover concurrent taVNS/fMRI trial
- Population
- healthy adults aged 18-45 years
- Sample size
- 17
- Device
- Digitimer DS7a constant-current stimulator
- Stimulation site
- left tragus
- Laterality
- left
- Contact system
- custom 1 cm round Ag/AgCl electrodes on 3D-printed clamps with Ten20 conductive paste
- Frequency
- 25 Hz
- Pulse width
- 500 μs
- Waveform
- monophasic square waves
- Intensity
- 200% of individual perceptual threshold; mean active tragus current 3.14 ± 0.99 mA
- Duty cycle
- 60 s on / 60 s off
- Session duration
- 6 min per concurrent taVNS/fMRI run
- Schedule
- two scanning visits separated by at least one day; three identical taVNS/fMRI scans per visit
- Comparator
- left earlobe electrical stimulation
- Outcome domains
- fMRI BOLD / central target engagement, tolerability
- Protocol notes
- Auricular fMRI protocol row. It describes this exact experimental protocol and does not establish equivalence with another device or evidence for Neuvago.
- Verified date
- 2026-09-28
AuricularProtocol 06
Stavrakis S, Humphrey MB, Scherlag BJ, et al. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015;65(9):867-875.
Population
patients with paroxysmal atrial fibrillation presenting for AF ablation
Stimulation site
right ear tragus
Frequency
20 Hz
Session duration
1 h
View reported protocol fields
- Study type
- randomized sham-controlled proof-of-concept human study during atrial fibrillation ablation
- Population
- patients with paroxysmal atrial fibrillation presenting for AF ablation
- Sample size
- 40
- Device
- Grass S88 stimulator
- Stimulation site
- right ear tragus
- Laterality
- right
- Contact system
- flat metal clip cathode on right tragus with a second clip on the earlobe/adjacent site as anode
- Frequency
- 20 Hz
- Pulse width
- 1000 μs
- Waveform
- square wave
- Intensity
- 50% below the individual voltage threshold that slowed sinus rate or prolonged AV nodal conduction
- Duty cycle
- continuous
- Session duration
- 1 h
- Schedule
- single 1-hour stimulation period during the AF ablation procedure after baseline measurements
- Comparator
- sham procedure with threshold measurement but no LLTS delivered
- Outcome domains
- atrial fibrillation electrophysiology, inflammatory biomarkers
- Protocol notes
- Acute auricular LLTS protocol during an invasive AF-ablation workflow. The protocol row is not a treatment recommendation or product comparison.
- Verified date
- 2026-09-28
AuricularProtocol 07
Yang H, Shi W, Fan J, et al. Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial. Neurotherapeutics. 2023;20(3):870-880.
Population
adults aged 18-65 years with drug-resistant epilepsy on stable anti-seizure medication
Stimulation site
ear conch
Frequency
25 Hz
Session duration
2 h/day divided into four 30-min periods
View reported protocol fields
- Study type
- multicenter randomized double-blind controlled trial
- Population
- adults aged 18-65 years with drug-resistant epilepsy on stable anti-seizure medication
- Sample size
- 150
- Device
- TVNS-100 (Xinzhile, Jiangxi, China)
- Stimulation site
- ear conch
- Laterality
- Not reported
- Contact system
- ear electrode with double stimulation points
- Frequency
- 25 Hz
- Pulse width
- 250 μs
- Waveform
- Not reported
- Intensity
- individually maintained at the maximum tolerated intensity of pain
- Duty cycle
- 30 s on / 30 s off
- Session duration
- 2 h/day divided into four 30-min periods
- Schedule
- daily stimulation for 20 weeks; 2 h/day in four 30-min periods
- Comparator
- same treatment period at 1 Hz with minimum perceptible tingling
- Outcome domains
- seizure frequency / responder rate, quality of life, mood, cognition, safety
- Protocol notes
- Auricular epilepsy protocol row. Ear laterality is left NR because the locked study-treatment section does not explicitly assign treatment laterality.
- Verified date
- 2026-09-28
CervicalProtocol 08
Tassorelli C, Grazzi L, de Tommaso M, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018;91(4):e364-e373.
Population
adults aged 18-75 years with episodic migraine with or without aura
Stimulation site
right and left sides of the neck
Frequency
25 Hz
Session duration
bilateral 120-s stimulations
View reported protocol fields
- Study type
- multicenter double-blind randomized parallel-group sham-controlled trial
- Population
- adults aged 18-75 years with episodic migraine with or without aura
- Sample size
- 248
- Device
- gammaCore (electroCore, LLC)
- Stimulation site
- right and left sides of the neck
- Laterality
- bilateral
- Contact system
- Not reported
- Frequency
- 25 Hz
- Pulse width
- Not reported
- Waveform
- 1 ms burst of five 5 kHz sine waves, each 200 μs, repeated once every 40 ms
- Intensity
- 24 V peak voltage and 60 mA peak output current
- Duty cycle
- Not reported
- Session duration
- bilateral 120-s stimulations
- Schedule
- within 20 min of migraine pain onset; repeat bilateral stimulation if not improved at 15 min, with an optional additional set at 120 min if not pain-free
- Comparator
- sham device producing a 0.1 Hz biphasic perceived signal
- Outcome domains
- migraine pain freedom / pain relief, associated symptoms, safety/tolerability
- Protocol notes
- Cervical nVNS waveform row. A conventional pulse_width_us value is left NR; the reported proprietary burst structure is preserved in waveform.
- Verified date
- 2026-09-28
ImplantedProtocol 09
Dawson J, Liu CY, Francisco GE, et al. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021;397(10284):1545-1553.
Population
people with moderate to severe arm weakness at least nine months after ischaemic stroke
Stimulation site
Not reported
Frequency
30 Hz
Session duration
0.5 s per movement-triggered stimulation train
View reported protocol fields
- Study type
- pivotal randomized triple-blind sham-controlled device trial
- Population
- people with moderate to severe arm weakness at least nine months after ischaemic stroke
- Sample size
- 108
- Device
- Not reported
- Stimulation site
- Not reported
- Laterality
- Not reported
- Contact system
- Not reported
- Frequency
- 30 Hz
- Pulse width
- 100 μs
- Waveform
- Not reported
- Intensity
- 0.8 mA active target; 0.7 and 0.6 mA in two participants after tolerance adjustment
- Duty cycle
- Not reported
- Session duration
- 0.5 s per movement-triggered stimulation train
- Schedule
- in-clinic rehabilitation three times per week for six weeks (18 sessions), followed by daily home exercises; home sessions used 30 min of active or sham VNS after a magnet swipe
- Comparator
- rehabilitation paired with 0 mA sham stimulation
- Outcome domains
- upper-limb motor impairment, upper-limb function, safety
- Protocol notes
- Implanted paired-VNS rehabilitation row. Exact device model, implant site/laterality, contact system and waveform are left NR because they are not explicitly specified in the locked primary article fields used for this extraction.
- Verified date
- 2026-09-28
ImplantedProtocol 10
Zannad F, De Ferrari GM, Tuinenburg AE, et al. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015;36(7):425-433.
Population
symptomatic heart failure patients with severe left-ventricular systolic dysfunction on guideline-recommended medical therapy
Stimulation site
right cervical vagus nerve
Frequency
20 Hz
Session duration
Not reported
View reported protocol fields
- Study type
- randomized sham-controlled implanted VNS trial
- Population
- symptomatic heart failure patients with severe left-ventricular systolic dysfunction on guideline-recommended medical therapy
- Sample size
- 96
- Device
- NECTAR-HF implanted VNS system with Precision pulse generator and bipolar helical vagal cuff lead
- Stimulation site
- right cervical vagus nerve
- Laterality
- right
- Contact system
- self-sizing bipolar helical vagal cuff lead
- Frequency
- 20 Hz
- Pulse width
- 300 μs
- Waveform
- Not reported
- Intensity
- titrated to tolerability up to 4 mA chronically; mean 1.24 ± 0.74 mA after the third titration
- Duty cycle
- 10 s on / 50 s off
- Session duration
- Not reported
- Schedule
- three stimulation titrations within 30 days after baseline, followed by six months of active chronic stimulation; control devices remained off
- Comparator
- implanted control group titrated for blinding, then stimulation turned off
- Outcome domains
- cardiac remodeling/function, exercise capacity, quality of life, autonomic/Holter measures, circulating biomarkers, safety
- Protocol notes
- Implanted right-sided chronic VNS protocol row. The trial-level protocol is preserved without converting study outcomes into device recommendations.
- Verified date
- 2026-09-28
AuricularProtocol 11
Zhang S, Zhao Y, Qin Z, et al. Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Insomnia Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(12):e2451217.
Population
adults aged 18-70 years with chronic insomnia disorder and PSQI >=8
Stimulation site
bilateral cymba conchae and cavum conchae
Frequency
4 Hz, 20 Hz
Session duration
30 minutes
View reported protocol fields
- Study type
- parallel-group randomized sham-controlled clinical trial
- Population
- adults aged 18-70 years with chronic insomnia disorder and PSQI >=8
- Sample size
- 72
- Device
- Hwato SDZ-II B electroacupuncture instrument
- Stimulation site
- bilateral cymba conchae and cavum conchae
- Laterality
- bilateral
- Contact system
- special silica-gel ear clips
- Frequency
- 4 Hz, 20 Hz
- Pulse width
- 200 μs
- Waveform
- dilatational wave alternating 4 Hz and 20 Hz epochs
- Intensity
- 0.8-1.5 mA, adjusted to maximum tolerable level
- Duty cycle
- Not reported
- Session duration
- 30 minutes
- Schedule
- twice daily, 5 consecutive days per week for 8 weeks, followed by 12-week follow-up
- Comparator
- sham taVNS at the same auricular sites and parameters with 0.1 mA current
- Outcome domains
- sleep quality and insomnia severity, mental health, sleepiness and fatigue, safety
- Protocol notes
- Study-specific insomnia protocol; no device-equivalence or Neuvago product-evidence transfer is implied.
- Verified date
- 2026-09-28
AuricularProtocol 12
Rong P, Liu J, Wang L, et al. Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: a nonrandomized controlled pilot study. J Affect Disord. 2016;195:172-179.
Population
adults aged 18-70 years with mild or moderate major depressive disorder
Stimulation site
auricular concha
Frequency
20 Hz
Session duration
30 minutes
View reported protocol fields
- Study type
- nonrandomized controlled clinical pilot study
- Population
- adults aged 18-70 years with mild or moderate major depressive disorder
- Sample size
- 160
- Device
- ear vagus nerve stimulator developed with Suzhou Medical Appliance Factory
- Stimulation site
- auricular concha
- Laterality
- Not reported
- Contact system
- special ear-clip electrodes
- Frequency
- 20 Hz
- Pulse width
- 200 μs
- Waveform
- continuous sinusoidal wave
- Intensity
- typically 4-6 mA, increased to the highest tolerable level
- Duty cycle
- continuous stimulation during each session
- Session duration
- 30 minutes
- Schedule
- twice daily; real cohort for 12 weeks, comparison cohort 4 weeks sham then 8 weeks real taVNS
- Comparator
- sham stimulation at the superior scapha with otherwise identical procedures and parameters
- Outcome domains
- depression severity, anxiety symptoms, response and remission
- Protocol notes
- Nonrandomized study; sham differed mainly by ear location. Preserve design limitations and avoid product-evidence transfer.
- Verified date
- 2026-09-28
AuricularProtocol 13
Wang R, Liu M, Liu Q, et al. Home-based transcutaneous auricular vagus nerve stimulation (taVNS) improves motor and non-motor symptoms by improving autonomic and brain functions in patients with Parkinson's disease: A randomized clinical trial. Neurotherapeutics. 2026;23(1):e00832.
Population
patients with Parkinson's disease on stable medication
Stimulation site
bilateral cymba conchae
Frequency
5 Hz
Session duration
30 minutes
View reported protocol fields
- Study type
- single-blinded placebo-controlled randomized clinical trial
- Population
- patients with Parkinson's disease on stable medication
- Sample size
- 49
- Device
- SNM-FDC01 wearable digital stimulator, Ningbo MedKinetic
- Stimulation site
- bilateral cymba conchae
- Laterality
- bilateral
- Contact system
- silicon electrodes
- Frequency
- 5 Hz
- Pulse width
- 500 μs
- Waveform
- Not reported
- Intensity
- 1.5-10 mA, individually adjusted to maximal tolerable non-painful tingling
- Duty cycle
- 10 s on / 60 s off
- Session duration
- 30 minutes
- Schedule
- twice daily at approximately 08:00 and 20:00 for 3 weeks
- Comparator
- sham stimulation at the inner arm near the elbow using the same stimulation parameters
- Outcome domains
- motor symptoms, quality of life and non-motor symptoms, autonomic biomarkers, brain imaging, safety
- Protocol notes
- Home-based PD protocol with short 3-week treatment; findings remain study-specific and are not Neuvago product evidence.
- Verified date
- 2026-09-28
CervicalProtocol 14
Silberstein SD, Calhoun AH, Lipton RB, et al. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016;87(5):529-538.
Population
adults aged 18-65 years with chronic migraine and at least 15 headache days per month
Stimulation site
right side of the neck near the cervical vagus nerve
Frequency
Not reported
Session duration
two 120-second stimulations delivered 5-10 minutes apart per treatment
View reported protocol fields
- Study type
- prospective multicenter double-blind randomized sham-controlled pilot study with open-label extension
- Population
- adults aged 18-65 years with chronic migraine and at least 15 headache days per month
- Sample size
- 59
- Device
- gammaCore handheld noninvasive vagus nerve stimulator
- Stimulation site
- right side of the neck near the cervical vagus nerve
- Laterality
- right
- Contact system
- two stainless-steel contact surfaces with conductive gel
- Frequency
- Not reported
- Pulse width
- Not reported
- Waveform
- Not reported
- Intensity
- user-adjustable low-voltage output; 24 V peak and maximum 60 mA output
- Duty cycle
- Not reported
- Session duration
- two 120-second stimulations delivered 5-10 minutes apart per treatment
- Schedule
- three treatments daily; 2-month randomized phase followed by 6-month open-label nVNS
- Comparator
- identical-appearing sham device that did not deliver electrical stimulation
- Outcome domains
- safety and tolerability, headache days, acute medication use, adherence and satisfaction
- Protocol notes
- The randomized phase did not significantly reduce headache days versus sham; preserve this neutral finding and avoid product transfer.
- Verified date
- 2026-09-28
CervicalProtocol 15
Diener HC, Goadsby PJ, Ashina M, et al. Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial. Cephalalgia. 2019;39(12):1475-1487.
Population
adults with episodic migraine
Stimulation site
bilateral neck
Frequency
25 Hz
Session duration
two consecutive 120-second bilateral stimulations per treatment
View reported protocol fields
- Study type
- phase 3 prospective multicenter randomized double-blind sham-controlled parallel-group trial with open-label extension
- Population
- adults with episodic migraine
- Sample size
- 341
- Device
- gammaCore noninvasive vagus nerve stimulator, previous study model
- Stimulation site
- bilateral neck
- Laterality
- bilateral
- Contact system
- Not reported
- Frequency
- 25 Hz
- Pulse width
- Not reported
- Waveform
- five 5-kHz sine-wave cycles forming a 1-ms burst, repeated at 25 Hz
- Intensity
- 24 V peak voltage and 60 mA peak output current
- Duty cycle
- Not reported
- Session duration
- two consecutive 120-second bilateral stimulations per treatment
- Schedule
- three treatments daily, 6-8 hours apart; 12-week double-blind phase then 24-week open-label phase
- Comparator
- sham device producing a 0.1-Hz biphasic direct-current signal up to 28 V peak-to-peak
- Outcome domains
- migraine days, headache days, acute medication days, safety and adherence
- Protocol notes
- Active nVNS was not superior to sham in the ITT primary outcome; sham vagal activity was later identified. Preserve both facts.
- Verified date
- 2026-09-28
ImplantedProtocol 16
D'Haens G, Eberhardson M, Cabrijan Z, et al. Neuroimmune Modulation Through Vagus Nerve Stimulation Reduces Inflammatory Activity in Crohn's Disease Patients: A Prospective Open-label Study. J Crohns Colitis. 2023;17(12):1897-1909.
Population
adults with moderately to severely active treatment-refractory Crohn's disease
Stimulation site
left cervical vagus nerve
Frequency
10 Hz
Session duration
1 minute initially, increased to 2 minutes at week 4 and 5 minutes at week 6
View reported protocol fields
- Study type
- prospective open-label multicenter clinical study
- Population
- adults with moderately to severely active treatment-refractory Crohn's disease
- Sample size
- 17
- Device
- Cyberonics VNS Therapy System with Demipulse Model 103 pulse generator
- Stimulation site
- left cervical vagus nerve
- Laterality
- left
- Contact system
- PerenniaFLEX Lead Model 304 implanted around the cervical vagus nerve
- Frequency
- 10 Hz
- Pulse width
- 250 μs
- Waveform
- Not reported
- Intensity
- 0.25-2.0 mA, titrated in 0.25-mA increments to maximum tolerated output
- Duty cycle
- Not reported
- Session duration
- 1 minute initially, increased to 2 minutes at week 4 and 5 minutes at week 6
- Schedule
- daily magnet-activated stimulation; if not in remission at week 8, 5 minutes four times daily; 16-week study
- Comparator
- Not reported
- Outcome domains
- clinical Crohn's disease activity, endoscopic severity, inflammatory biomarkers, quality of life, safety
- Protocol notes
- Open-label refractory-Crohn protocol without a control arm; comparative efficacy and product transfer must not be inferred.
- Verified date
- 2026-09-28
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