tVNS-PP: Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Stimulation of inner tragus Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve |
Device: Transcutaneous vagus nerve stimulation
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)
|
| Sham Comparator: Stimulation of ear lobe Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve |
Device: Transcutaneous vagus nerve stimulation
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)
|
Outcome Measures
Primary Outcome Measures
- International RLS Severity Scale [Seven days]
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
- Time domain analysis of heart rate variability [Two days]
The standard deviation of the RR intervals (SDNN) and the root mean square of successive differences (RMSSD) in milliseconds.
- Spectral analysis of heart rate variability [Two days]
The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage.
- Spontaneous baroreceptor sensitivity [Two days]
The average baroreceptor sensitivity in ms/mmHg.
Secondary Outcome Measures
- Serum cytokine concentrations [Two days]
Interleukin-6, interleukin-8, interleukin-1ß and tumor necrosis factor alpha in pg/ml.
- Hospital Anxiety and Depression scale [Two days]
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.
- Median nerve stimulation [Two days]
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.
- Sudoscan [Two days]
Measurement of electrochemical skin conductance
- Brief Pain Inventory [Two days]
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.
- Short Form 12 (SF-12) [Two days]
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.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Male and female participants between 18 and 80 years old
-
Written informed consent
Exclusion criteria:
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Age younger than 18 years or older than 80 years
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Participants with somatic or mental comorbidities, especially malignant tumor diseases, cardiac insufficiencies > NYHA II, severe depressive episodes, psychosis or dementia
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Pregnancy or breast feeding
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Addictions to alcohol, medications or drugs (except tobacco)
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An existing legal guardianship
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Participation in another scientific study within the previous eight weeks before enrollment
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Restless Legs Syndrome patients with one of the following secondary predispositions: iron deficiency, polyneuropathy, prolapsed disk, spinal stenosis or chronic obstructive pulmonary disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center | Göttingen | Germany | 37073 |
Sponsors and Collaborators
- University Medical Center Goettingen
Investigators
- Principal Investigator: Thomas Meyer, Prof., University of Göttingen
- Principal Investigator: Elisabeth Veiz, M.Sc., University of Göttingen
- Principal Investigator: Christoph Herrmann-Lingen, Prof., University of Göttingen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 27/7/18