Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05639387
Other study ID # 2018/0988
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2019
Est. completion date September 1, 2019

Study information

Verified date December 2022
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Transcutaneous vagus nerve stimulation (tVNS) has been investigated as a potential treatment for epilepsy with inconsistent results. The combination of transcranial magnetic stimulation with electromyography (TMS-EMG) and electroencephalography (TMS-EEG) allows to investigate the neuromodulatory effect of interventions such as tVNS by evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs). The goal of this study is to objectively evaluate the effect of tVNS on cortical excitability with TMS-EMG and TMS-EEG. These findings are expected to provide insight in the mechanism of action and help identify more optimal stimulation paradigms. In this prospective single-blind cross-over study, 15 healthy subjects will undergo active and sham tVNS during 60 minutes, using a maximum tolerated stimulation current. Single and paired pulse TMS will be delivered over the right-sided motor hotspot to evaluate MEPs and TEPs before and after the intervention.


Description:

In the past two decades, vagus nerve stimulation (VNS)has become a valuable treatment option for patients with refractory epilepsy. However, VNS requires a surgical procedure associated with potential side effects. Therefore, the development of non-invasive devices that selectively target the vagus nerve fibers with a low risk profile has gained interest. Transcutaneous auricular VNS (tVNS) is such a non-invasive neurostimulation modality that targets the cutaneous receptive field of the auricular branch of the vagus nerve located in the outer ear. Up to date, tVNS has been investigated as a potential treatment for epilepsy with inconsistent results. The goal of this study is to investigate the effect of tVNS on cortical excitability. This will provide important insight into the underlying effects of this technique on brain neurophysiology. Cortical excitability will be investigated by combining transcranial magnetic stimulation with electromyography (TMS-EMG) and electroencephalography (TMS-EEG), evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs). In this prospective, single-blind, cross-over study, we will include 15 healthy male participants. They will undergo a TMS safety screening (TSS) questionnaire and clinical neurological examination before inclusion. Each participant will complete 2 sessions at least one week apart, one with active tVNS and one with sham tVNS. The intervention is tVNS by means of the Nemos® device which stimulates the cymba conchae at the outer ear. Stimulation parameters are set to a frequency of 25 Hz, a pulsewidth of 250 µs, 7 s ON, 18 s OFF. The output current is ramped up until the user feels a tingling sensation at the stimulation site, but should remain subthreshold to painful stimulation. Stimulation is delivered during 60 min.Sham stimulation is achieved by placing the electrode on the earlobe instead of the cymba conchae. Before and after the intervention 120 single TMS pulses, 120 paired pulses with an interstimulus interval of 3ms and 120 paired pulses with an interstimulus interval of 100ms will be delivered over the right motor hotspot. MEPs will be measured at the left first dorsal interosseus muscle. TEPs will be measured using a 64-channel TMS-compatible electrode cap. MEPS and TEPS will be preprocessed offline in Matlab. TEP and MEP morphology ( amplitude and latency) will be evaluated before and after the intervention to investigate changes in cortical excitability.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date September 1, 2019
Est. primary completion date August 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - estimated IQ > 70 - healthy volunteer, taken from anamensis, clinical neurological examination and clinical estimation of researcher - no history of central neurological condition - no treatment with neurotropic drugs - TMS safety screening questionnaire - ICF signed Exclusion Criteria: - intracranial metal objects/materials (excl teeth fillings): vascular clips, shrapnell electrodes below stimulation area - pacemaker, implanted defibrillator, permanent medication pump, cochlear implant or deep brain stimulation (DBS)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
actual tVNS
Active tVNS (stimulation on cymba conchae --> nervus vagus stimulation)
sham tVNS
Sham tVNS (stimulation on earlobe --> no nervus vagus stimulation)

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring the electric activity of the brain evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs) during transcutaneous nervus vagus stimulation. Using transcranial magnetic stimulation (TMS), the influence of the tVNS is measured. 60 minutes
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A