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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-21

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System

NCT01174498

Pain

COMPLETED NA

Respiratory-Gated Vagal Nerve Stimulation for Chronic Pain

NCT04053127

Chronic Pain

COMPLETED NA

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial

NCT06912334

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia

RECRUITING NA

Effects of taVNS on Postoperative Pain in Complex Spinal Surgery

NCT07330973

Postoperative Pain Postoperative Pain in Orthopaedics Postoperative Pain Management

NOT_YET_RECRUITING NA

Effect of taVNS on Patients With Disorders of Consciousness

NCT07284732

Disorders of Consciousness

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Restless Legs Syndrome Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stimulation of inner tragus

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

Group Type ACTIVE_COMPARATOR

Transcutaneous vagus nerve stimulation

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Transcutaneous vagus nerve stimulation

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes