NCT05007743

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Medical Center Goettingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Restless Legs Syndrome
• Chronic Pain

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-07-21
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2021-08-16
• Last updated: 2023-05-10

Locations

1 site across 1 country: Germany