Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls

Chronic Pain Clinical Trial

— tVNS-PP  

Official title:

Randomized Trial of Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007743
• Other study ID #: 27/7/18
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2019
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• Male and female participants between 18 and 80 years old

• Written informed consent

Exclusion criteria:

• Age younger than 18 years or older than 80 years

• Participants with somatic or mental comorbidities, especially malignant tumor diseases, cardiac insufficiencies > NYHA II, severe depressive episodes, psychosis or dementia

• Pregnancy or breast feeding

• Addictions to alcohol, medications or drugs (except tobacco)

• An existing legal guardianship

• Participation in another scientific study within the previous eight weeks before enrollment

• Restless Legs Syndrome patients with one of the following secondary predispositions:

iron deficiency, polyneuropathy, prolapsed disk, spinal stenosis or chronic obstructive pulmonary disease

Related Conditions & MeSH terms

• Chronic Pain
• Restless Legs Syndrome

Intervention

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)

Locations

Country	Name	City	State
Germany	University Medical Center	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Spectral analysis of heart rate variability	The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage.	Two days
Primary	Spontaneous baroreceptor sensitivity	The average baroreceptor sensitivity in ms/mmHg.	Two days
Secondary	Serum cytokine concentrations	Interleukin-6, interleukin-8, interleukin-1ß and tumor necrosis factor alpha in pg/ml.	Two days
Secondary	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.	Two days
Secondary	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
Secondary	Sudoscan	Measurement of electrochemical skin conductance	Two days
Secondary	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
Secondary	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