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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| t-VNS sytem Vagus stimulation | Active Comparator | Subjects experience a transcutaneous vagal stimulation by the t-VNS device |
|
| Sham transcutaneous stimulation | Sham Comparator | Sham stimulation with an attached t-VNS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerbomed t-VNS® transcutaneous stimulation | Device | Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic function measurement | assessed by skin conductance response (SCL), skin conductance reaction (SCR) | once a day, two days in total |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg | Regensburg | Bavaria | 93053 | Germany |
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|
| t-VNS Sham stimulation | Device | t-VNS Sham stimulation |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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