Clinical trial NCT05007743: Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
Official title: Randomized Trial of Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Restless Legs Syndrome
Chronic Pain
Keywords: RLS, vagus nerve stimulation
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A crossover design is used for the investigation of the healthy cohort and a parallel design will be used for the patient group
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: International RLS Severity Scale
timeFrame: Seven days
measure: Time domain analysis of heart rate variability
timeFrame: Two days
measure: Spectral analysis of heart rate variability
timeFrame: Two days
measure: Spontaneous baroreceptor sensitivity
timeFrame: Two days
Secondary outcomes:
measure: Serum cytokine concentrations
timeFrame: Two days
measure: Hospital Anxiety and Depression scale
timeFrame: Two days
measure: Median nerve stimulation
timeFrame: Two days
measure: Sudoscan
timeFrame: Two days
measure: Brief Pain Inventory
timeFrame: Two days
measure: Short Form 12 (SF-12)
timeFrame: Two days
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center
Study officials:
affiliation: University of Göttingen
name: Thomas Meyer, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Göttingen
name: Elisabeth Veiz, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Göttingen
name: Christoph Herrmann-Lingen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.