Randomized Trial of Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Restless Legs Syndrome
- Sponsor
- University Medical Center Goettingen
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Spectral analysis of heart rate variability
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Prof. Thomas Meyer
Head of Laboratory
University Medical Center Goettingen
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Spectral analysis of heart rate variability
Time Frame: Two days
The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage.
Spontaneous baroreceptor sensitivity
Time Frame: Two days
The average baroreceptor sensitivity in ms/mmHg.
Time domain analysis of heart rate variability
Time Frame: Two days
The standard deviation of the RR intervals (SDNN) and the root mean square of successive differences (RMSSD) in milliseconds.
International RLS Severity Scale
Time Frame: 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
Secondary Outcomes
- Hospital Anxiety and Depression scale(Two days)
- Median nerve stimulation(Two days)
- Brief Pain Inventory(Two days)
- Serum cytokine concentrations(Two days)
- Sudoscan(Two days)
- Short Form 12 (SF-12)(Two days)