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The tVNS-PP trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on autonomic functions, immune responses, and disease severity in chronic pain and restless legs syndrome (RLS) patients as compared to healthy controls.
A pilot study with healthy participants will investigate whether transcutaneous vagus nerve stimulation at the inner tragus reduces heart rate variability and lowers blood pressure without causing undesirable, severe side effects. In addition, changes in immune markers will be analyzed in blood samples before and after the interventions. Patients with primary restless legs syndrome will undergo a similar experimental protocol, except that transcutaneous vagus nerve stimulation will be performed daily. The aim is to determine whether stimulation reduces disease severity and chronic pain while improving quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation of inner tragus | Active Comparator | Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve |
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| Stimulation of ear lobe | Sham Comparator | Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagus nerve stimulation | Device | Frequency of 30 Hz, biphasic, rectangular pulses with a pulse width of 250 µs and an intensity of 20 mA. Device: Easy Tens+ device (body clock, London, UK) |
| Measure | Description | Time Frame |
|---|---|---|
| International RLS Severity Scale | Numeric score quantifying disease severity. This numeric rating scale ranges from 0 to 40 points. The higher the achieved score, the higher is the RLS disease severity. 0 points: no symptoms, 1-10 points: mild symptoms, 11-20 points: moderate symptoms, 21-30 points: severe symptoms, 31-40 points: extreme symptoms | Seven days |
| Time domain analysis of heart rate variability | The standard deviation of the RR intervals (SDNN) and the root mean square of successive differences (RMSSD) in milliseconds. | Two days |
| Spectral analysis of heart rate variability | The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage. | Two days |
| Spontaneous baroreceptor sensitivity | The average baroreceptor sensitivity in ms/mmHg. | Two days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokine concentrations | Interleukin-6, interleukin-8, interleukin-1ß and tumor necrosis factor alpha in pg/ml. | Two days |
| Hospital Anxiety and Depression scale | This questionnaire has 14 items that evaluate depression and anxiety symptoms. Each item has four possible responses and is scored in a range from zero to three with higher scores representing more symptoms. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Meyer, Prof. | University of Göttingen | Principal Investigator |
| Elisabeth Veiz, M.Sc. | University of Göttingen | Principal Investigator |
| Christoph Herrmann-Lingen, Prof. | University of Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Göttingen | 37073 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35576915 | Derived | Veiz E, Kieslich SK, Czesnik D, Herrmann-Lingen C, Meyer T, Staab J. Increased Concentrations of Circulating Interleukins following Non-Invasive Vagus Nerve Stimulation: Results from a Randomized, Sham-Controlled, Crossover Study in Healthy Subjects. Neuroimmunomodulation. 2022;29(4):450-459. doi: 10.1159/000524646. Epub 2022 May 16. |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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A crossover design is used for the investigation of the healthy cohort and a parallel design will be used for the patient group
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| Two days |
| Median nerve stimulation | Electrical nerve stimulation of the median nerve to assess its strength-duration time constant (SDTC) or chronaxie in milliseconds. The SDTC is a measure of axonal excitability and provides indirect information about the functionality of sodium ion channels. | Two days |
| Sudoscan | Measurement of electrochemical skin conductance | Two days |
| Brief Pain Inventory | This questionnaire assesses pain severity, location of pain, and impact on daily functions in the past 24 hours. Pain severity is scored on a numeric scale from zero to ten, with zero being no pain and ten being the worst possible pain. | Two days |
| Short Form 12 (SF-12) | This questionnaire assesses the quality of life using 12 items. Each item is scaled on a range between zero and a maximum of six. Weighted sums are calculated and transformed into a population-standardized score ranging between zero and 100. The higher the score, the better is the respective life quality compared to the average population. | Two days |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |