Vagus nerve stimulation for fibromyalgia has been studied, but the work is early. The two pilots this page covers are uncontrolled: Lange’s 2011 pilot of 14 people with implanted devices, and Dolcini’s 2025 pilot of 18 people using ear-based stimulation. Neither compared stimulation with a sham (fake stimulation) group, and a 2025 systematic review by Perin and colleagues says small samples and differing sham definitions and parameters “limit current interpretability.” Below you will find what each study found, what the FDA has and has not approved, and what to ask before you consider a device.
For wider context on where this research sits, see our complete guide to vagus nerve research in chronic pain conditions like fibromyalgia.
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Quick facts (2026-11-11)
| Fact | What the sources show (2026-11-11) |
|---|---|
| Fibromyalgia pilots covered here using vagus stimulation | Two uncontrolled pilots: Lange 2011 (14 people, implanted device) and Dolcini 2025 (18 people, ear-based therapy) |
| Reviews that include vagus stimulation | Pellow 2025 (non-invasive vagus stimulation for chronic pain) and Perin 2025 (VNS and fibromyalgia) |
| Registered fibromyalgia trials | Three, with start dates in 2023, 2024 and 2026; one is a sham-controlled trial that is not yet recruiting |
| FDA approval or clearance for fibromyalgia | None of the FDA records covered here lists fibromyalgia |
| FDA clearance for vagus devices | gammaCore Sapphire, for headache uses (migraine and cluster headache) |
| FDA approval for implanted vagus devices | Epilepsy (1997), depression (2005) and arm rehabilitation after stroke (2021) |
| Consumer vagus devices | Makers describe them as wellness, CE or FCC products, not as pain treatments |
Can a vagus nerve stimulator help with fibromyalgia?
The two pilots report improvements in pain and related symptoms in the people they studied. Each result belongs to the device and group in its own study. It does not carry over to other devices, to other conditions, or to products sold to consumers.
What the studies found, in date order
Lange 2011: implanted stimulator in 14 people
Lange and colleagues published an open-label phase I/II trial in Pain Medicine. You can read the Lange 2011 pilot trial in full.
- Device: a surgically implanted vagus nerve stimulator, not a wearable.
- Who: 14 people with treatment-resistant fibromyalgia.
- Comparison: none. The authors call it an uncontrolled pilot study.
- Length: 3 months of stimulation, with follow-up visits at 5, 8 and 11 months.
- Results: 12 people completed the first 3 months. At 3 months, 5 people met the composite criteria for pain, overall wellness and physical function. Two of those 5 no longer met the widespread pain or tenderness criteria for fibromyalgia. More people met the criteria at 11 months.
- Side effects: similar to those seen with implanted VNS for epilepsy and depression, plus dry mouth and fatigue. Two people did not tolerate stimulation.
- Authors’ words: VNS “may be a useful adjunct treatment” for resistant fibromyalgia, but “further research is required.”
Dolcini 2025: ear-based stimulation in 18 people
Dolcini and colleagues titled their paper “Vagal nerve stimulation and fibromyalgia: an additional therapeutic option,” published in Clinical and Experimental Rheumatology on 27 June 2025. The Dolcini 2025 pilot study abstract is on PubMed.
- Device: auricular vagal neuromodulation therapy (AVNT), a non-invasive, ear-based therapy.
- Who: 18 people with fibromyalgia.
- Comparison: a single group. The abstract describes no control arm.
- Length: 4 weeks.
- Results: the widespread pain index fell at week 2 (p = 0.03) and at week 4 (p = 0.004). At week 4, the revised FIQ total (p = 0.02), general health (p = 0.002), symptoms (p < 0.001) and sleep (PSQI, p = 0.02) improved. Serum BDNF did not change significantly.
Pellow 2025: review of non-invasive vagus stimulation for chronic pain
Pellow and colleagues reviewed randomized trials published from 2010 to 2023 in the Scandinavian Journal of Pain. The Pellow 2025 systematic review is on PubMed.
- Who: 1,474 records were found and 10 articles were included, with 813 participants in total: 763 on non-invasive vagus nerve stimulation (nVNS) and 50 on heart rate variability biofeedback.
- Fibromyalgia part: of the 9 nVNS studies, 2 studied fibromyalgia symptoms (138 people). Six studied headache or migraine (603 people) and 1 studied chronic low back pain (22 people). The headache results belong to headache.
- Outcomes across the nVNS studies: 3 reported significant results for episode frequency, 6 for pain intensity and 3 for medication use.
- Authors’ conclusion: they rate the evidence that nVNS reduces headache frequency as moderate to high quality, and say it is well tolerated. For chronic pain conditions, they wrote that “insufficient literature exists to support either approach.”
Perin 2025: systematic review of VNS and fibromyalgia
Perin and colleagues published a systematic review in Journal of Functional Morphology and Kinesiology on 29 December 2025. They searched on 24 October 2025.
- Included: 6 studies on VNS effects, 4 clinical studies and 2 protocols. A protocol is a study plan, not a result.
- Reported: the review’s abstract reports “improvements in pain, fatigue, sleep disturbance and autonomic regulation.”
Registered fibromyalgia trials, by start date
- Kasr El Aini Hospital (Egypt): study start 30 September 2023; status completed; estimated completion 15 March 2025. Women aged 18 to 55 were listed, with 87 total participants. Three arms: non-invasive vagus stimulation alone, stimulation plus medical treatment, and medical treatment alone.
- Massachusetts General Hospital: study start 1 July 2024; status active, recruiting; estimated completion 31 October 2029. 60 participants in two groups of 30, with pain intensity as the primary outcome and fatigue, sleep and health-related quality of life as secondary outcomes. Eligibility asked for a pain score of 4 or above on a 0 to 10 scale. The listing was updated 10 September 2026.
- Hasan Kalyoncu University (Turkey): first posted 26 October 2026; status not yet recruiting; estimated start 2 November 2026. This is a randomized, sham-controlled study adding non-invasive vagus stimulation to manual therapy in women with fibromyalgia, with pain, autonomic function and illness perception as outcomes. The ClinicalTrials.gov record NCT07894588 shows no results posted.
What the findings do not show
- The two pilots covered here are uncontrolled and compare nothing against a sham. The only registered sham-controlled trial in this group is not yet recruiting.
- Results from headache studies, TENS trials, and implanted epilepsy, depression or stroke devices belong to those uses. They do not describe fibromyalgia.
- A protocol describes a plan for a study. It is not a finding.
Approved, cleared or wellness: what the words mean
These terms are often mixed up. The FDA page explains the first three in its own words, and the makers describe the rest on their own pages.
| Term | What the source says it means |
|---|---|
| 510(k) clearance | A premarket submission showing a device is substantially equivalent to a device already legally marketed. The FDA device approvals and clearances page explains it. |
| PMA approval | The FDA calls the premarket approval the most stringent type of device marketing application. It requires sufficient valid scientific evidence of safety and effectiveness for the intended use. |
| De Novo | An alternate route for novel devices of low to moderate risk, per the FDA page. |
| General wellness | A label makers use. Truvaga’s FAQ says its devices “are considered a wellness product and are not covered by health insurance.” Pulsetto says it is “considered a general wellness device.” |
| CE | Nurosym’s help article calls its device a “certified device (CE) in Europe” and says CE “is the only valid medical device certificate in Europe.” |
| FCC | Nurosym’s help article says FCC certification means a product meets FCC emission rules, and that it “does not imply that the product is safe or durable.” Pulsetto says its device is “FCC-certified.” |
Which vagus devices have FDA records, and for what
| Device or use | What the FDA record or page says |
|---|---|
| Implanted VNS for epilepsy | FDA approved the VNS Therapy on 16 July 1997 as an add-on therapy for reducing seizures in people with partial-onset seizures. See the implanted VNS FDA premarket record. |
| Implanted VNS for depression | The FDA summary of supplement S207 says a depression indication followed in June 2005. |
| Vivistim for stroke arm rehabilitation | FDA approved the Vivistim paired VNS system (decision date 27 August 2021) to be used with rehabilitation therapy for moderate to severe arm impairment after chronic ischemic stroke. See the Vivistim FDA approval record. |
| gammaCore Sapphire, neck device | FDA cleared it through 510(k) K211856 (decision 10 September 2021). Its indications are migraine headache and cluster headache, not fibromyalgia or general pain. See the gammaCore Sapphire FDA record. |
| TENS for pain relief | The federal rule classifies this as a Class II device for pain relief, under 21 CFR 882.5890. It is a different device from vagus stimulators. |
Consumer vagus devices and what their makers say
Several consumer devices are sold with vagus nerve language. Their makers describe them for stress, relaxation and general wellbeing. Truvaga says its devices support “a balanced nervous system.” Apollo Neuro says its wearable is intended to help manage stress, challenging life transitions and to promote a healthy lifestyle, and it describes vibration rather than electrical current. Pulsetto calls its neckband a general wellness device and says it does not claim to diagnose, treat, cure or prevent any condition. Nuropod, an ear device, says it is “scientifically proven to modulate the vagus nerve,” and its page lists “Third party certified device.” These are the makers’ own statements.
Side effects and who should avoid each option
Cleveland Clinic’s vagus nerve stimulation overview covers the implanted device. The table lists what each source reports.
| Device or therapy | Side effects or cautions the source lists |
|---|---|
| Implanted VNS (Cleveland Clinic) | Coughing, hoarseness, voice change, neck or throat pain, shortness of breath, trouble speaking or swallowing, and headache. Serious ones listed include vocal cord paralysis, infection and device complications. |
| Implanted VNS in the Lange 2011 pilot | Side effects similar to those for epilepsy and depression VNS, plus dry mouth and fatigue. Two of 14 people did not tolerate stimulation. |
| gammaCore (manufacturer) | Not for people with an active implanted device such as a pacemaker, hearing aid implant or other implanted electronic device; not for people with a metal stent, bone plate or bone screw at or near the neck; and not to be used at the same time as another device such as a TENS unit. |
| Truvaga (manufacturer) | Says fewer than 5% of participants in its clinical studies had mild effects: site discomfort or redness, muscle twitching, localized face, head or neck pain (including toothache), mild headache or mild dizziness. Not intended for anyone with an active implantable medical device, such as a pacemaker. |
| Pulsetto (manufacturer) | Its list of who should not use it includes people with a heart condition, irregular heartbeat, blood pressure problems, or a history of seizures or fainting; people with neck surgery; people with an electronic implant such as a pacemaker, or metal implants near the neck; pregnancy; cancer treatment; and broken or damaged skin on the neck. Intended for adults aged 18 and over. |
| Nuropod (manufacturer) | Listed as not suitable: people who have had cervical vagotomy, people with a severe low resting heart rate, people with a permanent implanted metallic or electronic device or jewelry close to the ear, and pregnant women. Children and people with severe coronary disease or a heart attack within 5 years are also listed as contraindications. |
| TENS (NHS and Cleveland Clinic) | Adhesive allergy, prickling or tingling, and rare electrode burns. The NHS says not to use it with epilepsy or a pacemaker, and not in pregnancy unless a doctor or midwife says so. |
Is nerve pain the same as muscle pain?
Pain is often sorted into two groups. Nerve pain, called neuropathic pain, comes from damaged nerve fibers that send faulty signals. Cleveland Clinic on neuropathic pain describes it as burning, stabbing or electric shock-like, with tingling and numbness. Tissue pain, called nociceptive pain, is the discomfort you feel when tissue is damaged, most often in muscles, joints and bones. WebMD on nociceptive pain describes it as dull, achy, sharp, throbbing or cramping.
Cleveland Clinic says to contact a provider for numbness, tingling, muscle weakness, uncontrolled twitching, or frequently dropping held objects. Keep a simple log of which words describe your pain, when it starts, and what changes it. Bring that log to your clinician. For nerve-type pain that starts in the spine, see pinched nerve symptoms and questions.
TENS and vagus stimulation are different things
TENS sends a low-voltage current through pads on the skin. The NHS guide to TENS says it is thought to work by encouraging the body to release endorphins, and that “TENS does not work for everyone.” Cleveland Clinic’s TENS overview lists fibromyalgia among the conditions where TENS is used.
The Cochrane review of TENS for fibromyalgia looked at 8 studies with 315 adults. Its authors rated the quality of evidence as “very low” and wrote there was “insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia.” That review covers TENS, so its results do not transfer to vagus stimulation.
Does posture or text neck change the vagus nerve?
A 2025 cross-sectional study of 84 young adults in Cureus, the text neck and autonomic function study, found that a more forward head posture went with higher sympathetic activity and lower parasympathetic activity, measured through heart rate variability. The authors describe this as an association with forward head posture, measured through heart rate variability.
A 2025 Frontiers in Neurology paper by Hauser and colleagues proposes that forward-head phone use may affect the vagus nerve. It is based on a retrospective chart review of 234 patients, and the authors say symptom resolution with better vagus nerve measurements “will prove this hypothesis.” The authors also promote the neck treatments they propose, as described in the Hauser cervicovagopathy paper.
Where the devices reach the vagus nerve
The vagus nerve is one of the longest nerves in the body, according to Northwell’s vagus nerve stimulation overview. The Hasan Kalyoncu registry description says non-invasive transcutaneous devices reach it either through the auricular route at the ear or at the carotid. Hauser and colleagues describe the two vagus nerves as lying in the carotid sheath just in front of the cervical vertebrae.
Common mix-ups
- TENS is not vagus stimulation. Its trials and FDA class do not transfer.
- Headache devices are not fibromyalgia devices. The gammaCore indications cover headache only.
- “FDA approved,” “FDA cleared” and “wellness” are different. The terms table above shows the difference.
- Posture research is about association. It does not show that a posture change alters vagal function.
Who to ask before you try one
Start with your primary care clinician, who knows your full history and can look at any device you are considering. A neurologist can assess nerve-type symptoms, and a physical therapist can help plan movement and pain management. For back pain at work, see our living and working with back pain guide.
Questions that settle your next step
- Which FDA record covers the exact use the seller advertises? Ask for the number and check the FDA device approvals and clearances page.
- Is the device FDA approved, FDA cleared, or sold as a general wellness product? The maker’s own wording answers this.
- Do any of the cautions in the side effects table apply to you, such as an implanted device or a pacemaker?
- Has the sham-controlled trial, ClinicalTrials.gov record NCT07894588, posted results? Check the record for updates.
- What is the refund window, and what does the return cover? Check the seller’s order page before you buy.
- Bring a two-week log of your pain score, sleep and the time of day to your clinician.
By BackToHealthTroy.com Editorial Team
This article is for general information purposes only and does not constitute medical advice. Consult your doctor or qualified healthcare provider before making changes to your health routine.