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

NCT05007743 | Unknown

• 1 other identifier: 27/7/18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome; Chronic Pain

Keywords

RLS, vagus nerve stimulation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Spectral analysis of heart rate variability

  The normalized high frequency component of the RR intervals (HF-HRV) is expressed as a percentage.

  Two days

• Spontaneous baroreceptor sensitivity

  The average baroreceptor sensitivity in ms/mmHg.

  Two days

Secondary Outcomes (6)

• Serum cytokine concentrations

  Two days

• Hospital Anxiety and Depression scale

  Two days

• Median nerve stimulation

  Two days

• Sudoscan

  Two days

• Brief Pain Inventory

  Two days

Study Arms (2)

Stimulation of inner tragus

ACTIVE COMPARATOR

Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve

Device: Transcutaneous vagus nerve stimulation

Stimulation of ear lobe

SHAM COMPARATOR

Comparing autonomic hemodynamic functions and immune responses pre- and post-stimulation of the vagus nerve

Device: Transcutaneous vagus nerve stimulation

Interventions

Transcutaneous vagus nerve stimulation DEVICE

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)

Stimulation of ear lobe; Stimulation of inner tragus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants between 18 and 80 years old
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center

Göttingen, 37073, Germany

Location

Related Publications (1)

• 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.

  PMID: 35576915 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Meyer, Prof.

  University of Göttingen

  PRINCIPAL INVESTIGATOR

• Elisabeth Veiz, M.Sc.

  University of Göttingen

  PRINCIPAL INVESTIGATOR

• Christoph Herrmann-Lingen, Prof.

  University of Göttingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory

Model Details: A crossover design is used for the investigation of the healthy cohort and a parallel design will be used for the patient group

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 16, 2021
• Study Start: July 21, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

DE (1)