Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System

Study Overview
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Brief Summary
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The increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies. In the recent years neurostimulating techniques have been a promising approach regarding their analgesic effect. Combined with therapeutic standard procedures they can increase these effects and can have a positive impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient analgesic method in animal experiments and open clinical pilot studies amongst humans. Despite the lack of controlled approaches applying the method against defined pain syndromes, the stimulation of the vagus nerve has shown up as an effective method treating other psychiatric diseases like depression. The processing of stress, which is involved directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation. Compared with invasive methods the transcutaneous stimulation offers obvious advantages concerning appliance and occurrence of side effects. There are no studies so far dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of defined (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change of experiencing pain when applying the t-VNS in healthy subjects.

Official Title
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Controlled, Randomized Study of Pain Perception and Psychophysiological Reactions of the Autonomic Nervous System Under Transcutaneous, Electrical Stimulation of the Vagus Nerve in Healthy Volunteers

Conditions
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Pain

Intervention / Treatment
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* Device: Cerbomed t-VNS® transcutaneous stimulation
* Device: t-VNS Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: Minimum: 18 years Maximum: no limit Both Gender Normal psychiatric medical history Normal neurological report Exclusion Criteria: Psychiatric disease incl. pain-related diseases Subject is on medication Abuse of drugs or alcohol until 12 weeks before enrollment in the study Actual wearing conditions Pronounced lack of sleep within the last 2 days of enrollment Excessive consumption of alcohol in the last 2 days Peripheral neuropathy Severe neurological diseases (cerebrovascular diseases, traumatic brain injury, epilepsy, Morbus Parkinson, dementia, systemic neurologic diseases etc.) migraine carpal tunnel syndrome or other entrapment syndromes missing Informed Consent Pregnancy active implant (like cochlea implant, VNS, pacemaker) severe internistic diseases (e.g. arterial hypertension, respiratory failure) malignant diseases within the last five years severe acute infections (e.g. HIV, hepatitis) diseases of the ENT bodysystem: Hearing loss of the left ear which is treated with an hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: t-VNS sytem Vagus stimulation<br>Subjects experience a transcutaneous vagal stimulation by the t-VNS device | Device: Cerbomed t-VNS® transcutaneous stimulation<br>* Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.<br>* Other names: Cerbomed t-VNS®;|
| Sham Comparator: Sham transcutaneous stimulation<br>Sham stimulation with an attached t-VNS device | Device: t-VNS Sham stimulation<br>* t-VNS Sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QST- Quantitative Sensory Testing | measurement of pain with the qst method before and after the transcutaneous stimulation | twice a day, two days in total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic function measurement | assessed by skin conductance response (SCL), skin conductance reaction (SCR) | once a day, two days in total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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discomfort, distress, hurt, sting