Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-10-31

Brief Summary

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

Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.

Related Clinical Trials

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

Vagus Nerve Stimulation in Fibromyalgia

NCT06237595

Fibromyalgia

RECRUITING NA

Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia

NCT00294281

Fibromyalgia

COMPLETED PHASE1

taVNS Treatment for Fibromyalgia

NCT04777500

Fibromyalgia

NOT_YET_RECRUITING 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 Fibromyalgia Pain

NCT06193317

Fibromyalgia, Pain

NOT_YET_RECRUITING NA

Detailed Description

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

The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.

Conditions

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

Fibromyalgia

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Transcutaneous Vagus Nerve Stimulation(tVNS)

receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.

Group Type EXPERIMENTAL

Transcutaneous Vagus Nerve Stimulation

Intervention Type DEVICE

30 minutes stimulation, twice per day for 4 weeks

Sham Control group

receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Transcutaneous Vagus Nerve Stimulation

30 minutes stimulation, twice per day for 4 weeks

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

1. Subject is 18 to 80 years old, including both male and female subjects.
2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).

Exclusion Criteria

1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
3. Subject has active infection at the site of device application.
4. Subject has recurrent syncope symptoms within the past three months.
5. Subject is pregnant.
6. Subject has had VNS treatment within the past two months.

.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No