An interventional study of Transcutaneous Vagus Nerve Stimulation and Sham Transcutaneous Vagus Nerve Stimulation in Fibromyalgia Syndrome, sponsored by University of Roma La Sapienza. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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Among 41 studies in Fibromyalgia with a site in Italy — 16 open to participants now, 17 under way, none of them phase 3. Fibromyalgia · Italy.
Among the 41 studies in Fibromyalgia with a site in Italy, this one is the 16th largest by planned enrollment of the 31 interventional ones that give a count, is one of 6 that started in 2026, is one of 21 with no phase, reaches primary completion later than 11 of the 16 other live ones, and was the 36th registered.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →16 of the 41 studies in Fibromyalgia with a site in Italy are open now. Recruiting first, the newest first:
Istituto Giannina Gaslini · Sites in Italy
Ages 9–25
Italian Association for the Research and the Scientific Update · Sites in Italy
Ages 35–64 · Women only
IRCCS San Raffaele Roma · Sites in Italy
Ages 18–70
Universita degli Studi di Genova · Sites in Italy
Ages 18–65 · Women only
University of Bari · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 60 across 938 interventional studies indexed under Fibromyalgia.
Median enrollment 80 across the 31 interventional studies, 69 across the 10 observational. Of the 23 that completed or were terminated, 5 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 41 have an industry lead sponsor. The 10 most frequent:
University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
University of Roma La Sapienza has 6 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
8 of the studies in Fibromyalgia with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06135753University of FlorencePsychosomatic Intervention in Fibromyalgia. | 2026-12-30 |
| NCT07641374Italian Association for the Research and the Scientific UpdateAuricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia | 2026-12-31 |
| NCT07865403IRCCS San Raffaele RomaPsychologically Informed Telerehabilitation for Fibromyalgia | 2026-12-31 |
| NCT07785362Istituto Giannina GasliniNeuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome | 2027-03 |
| NCT07682090University of Roma La SapienzaTranscutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS) | 2027-05-25 |
Add all 8 to your calendar (.ics) → With an account.
Among the 41 studies in Fibromyalgia with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mechanism-based interventions.
Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that enhances parasympathetic activity through stimulation of the auricular branch of the vagus nerve. Preliminary studies suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life in patients with FMS, although available evidence is limited by small sample sizes and heterogeneous methodologies.
The RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of tVNS in patients with FMS. Participants will be randomized in a 1:1 ratio to receive either active tVNS or sham stimulation for four consecutive weeks. Stimulation will be administered daily for 30 minutes using the Nurosym™ device applied at the tragus of the external ear.
The primary objective is to assess the effect of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values.
Exploratory objectives include:
Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain associated with fatigue, sleep disturbances, cognitive symptoms, mood alterations, and autonomic dysfunction, leading to substantial impairment in quality of life and daily functioning. Current evidence supports the concept of FMS as a nociplastic pain disorder, in which altered central pain processing and impaired descending pain modulation play a key pathophysiological role. However, increasing evidence suggests that peripheral nervous system involvement and autonomic nervous system dysfunction may also contribute significantly to symptom generation and clinical heterogeneity in this condition.
Several studies have demonstrated that patients with FMS frequently exhibit cardiovascular autonomic dysfunction, characterized by sympathetic nervous system hyperactivity at rest and impaired autonomic adaptive responses during orthostatic challenge. These abnormalities have been documented through heart rate variability (HRV) analysis and other autonomic function tests and have been associated with orthostatic intolerance symptoms, fatigue, and pain severity. In addition, approximately 50% of patients with fibromyalgia show evidence of reduced intraepidermal nerve fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP). Recent findings suggest that small fiber involvement in FMS non è limitato alle piccole fibre somatiche, ma anche alle fibre autonomiche simpatiche post- gangliari. Il ruolo della SFP nella FMS è ancora sconosciuto, tuttavia un recente studio ha dimostrato come la SFP contribuisca alla disfunzione autonomica nella FMS.
Despite the availability of pharmacological and non-pharmacological therapeutic approaches, including antidepressants, gabapentinoids, physical therapy, and psychological interventions, treatment efficacy in FMS remains limited. Consequently, there is growing interest in mechanism-based neuromodulation strategies targeting autonomic dysfunction and central pain modulation pathways.
Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique designed to stimulate the auricular branch of the vagus nerve through cutaneous electrical stimulation applied to specific regions of the external ear. By enhancing parasympathetic activity and modulating central autonomic and pain-processing networks, tVNS has emerged as a promising therapeutic strategy for chronic pain disorders and conditions associated with autonomic imbalance. Preliminary studies in FMS suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life; however, currently available studies are limited by relatively small sample sizes and heterogeneous methodologies.
The RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of transcutaneous vagus nerve stimulation in female patients with fibromyalgia syndrome and to investigate clinical and biological predictors of treatment response.
Female participants meeting the diagnostic criteria for fibromyalgia according to the 2016 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria will be enrolled and randomized to receive either active tVNS or sham stimulation. Randomization will be computer-generated with variable block sizes in order to ensure allocation concealment and balance between groups throughout the enrollment period. Both participants and outcome assessors will remain blinded to treatment allocation.
The intervention will consist of daily 30-minute stimulation sessions administered for four consecutive weeks using the Nurosym™ device applied at the tragus of the external ear. Participants allocated to the active treatment group will receive standard transcutaneous vagus nerve stimulation, whereas the sham group will undergo identical procedures using a stimulation modality that does not deliver a therapeutic vagal stimulation pattern.
The primary objective of the study is to assess the efficacy of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values.
Exploratory objectives include:
Statistical analyses will be conducted according to the intention-to-treat principle. The primary endpoint will be analyzed using mixed-effects models for repeated measures with adjustment for baseline values. Exploratory analyses will evaluate treatment effects on autonomic function parameters and biomarker levels, as well as predictors of clinical response. Additional subgroup analyses will compare treatment response in patients with and without evidence of small fiber pathology.
The study is expected to provide clinically relevant evidence regarding the efficacy and safety of transcutaneous vagus nerve stimulation in fibromyalgia syndrome and to improve understanding of the relationship between autonomic dysfunction, peripheral nervous system involvement, and nociplastic pain mechanisms in this condition. Furthermore, the identification of predictors of response to vagal neuromodulation may contribute to the development of more personalized therapeutic strategies for patients with fibromyalgia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive active transcutaneous vagus nerve stimulation (tVNS) using the Nurosym™ device applied at the tragus of the external ear. Stimulation sessions will last 30 minutes and will be administered once daily for four consecutive weeks. Stimulation intensity will be individually adjusted by participants until a mild tingling sensation is perceived at the stimulation site. The device delivers an active therapeutic vagal stimulation pattern intended to modulate autonomic nervous system activity and pain processing pathways.
Device: Transcutaneous Vagus Nerve Stimulation
Participants assigned to this arm will receive sham transcutaneous vagus nerve stimulation using the Nurosym™ device applied at the tragus of the external ear. Sham stimulation sessions will last 30 minutes and will be administered once daily for four consecutive weeks. Participants will follow the same procedures used for active stimulation, including adjustment of stimulation intensity until a mild tingling sensation is perceived. However, after the session is initiated, the device will automatically reduce stimulation output to zero within a few seconds, without delivering an active therapeutic vagal stimulation pattern.
Device: Sham Transcutaneous Vagus Nerve Stimulation
Transcutaneous vagus nerve stimulation (tVNS) will be delivered using the Nurosym™ device applied at the tragus of the external ear. Participants will undergo one 30-minute stimulation session daily for four consecutive weeks. Stimulation intensity will be individually adjusted until a mild tingling sensation is perceived at the stimulation site. The intervention is designed to activate the auricular branch of the vagus nerve and modulate autonomic nervous system activity and pain-processing pathways.
Sham transcutaneous vagus nerve stimulation will be delivered using the Nurosym™ device applied at the tragus of the external ear. Participants will undergo one 30-minute session daily for four consecutive weeks and will follow the same procedures used for active stimulation, including adjustment of stimulation intensity until a mild tingling sensation is perceived. However, after initiation of the session, the device will automatically reduce stimulation output to zero within a few seconds and will not deliver an active therapeutic vagal stimulation pattern.
Change in Revised Fibromyalgia Impact Questionnaire (rFIQ) Score at Week 4
The primary outcome measure will be the difference between active transcutaneous vagus nerve stimulation and sham stimulation in the change from baseline to Week 4 in the revised Fibromyalgia Impact Questionnaire (rFIQ) score. The rFIQ is a validated questionnaire assessing the overall impact of fibromyalgia on daily functioning and symptom severity, with higher scores indicating greater disease burden. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to end of treatment at Week 4
Change in COMPASS-31 questionnaire at Week 4
Change from baseline to Week 4 in autonomic symptom burden measured using the Composite Autonomic Symptom Score (COMPASS-31). The questionnaire will be administered electronically through a REDCap-based application. Higher scores indicate greater autonomic symptom severity.
Time frame: From baseline to end of treatment at Week 4
Change in Sudomotor Function at Week 4
Changes in sudomotor function will be assessed using dynamic sweat testing (DST) performed at baseline and Week 4. DST will be used as a non-invasive measure of autonomic small-fiber function by evaluating sweat production and sudomotor responses.
Time frame: From baseline to end of treatment at Week 4
Change in Serum Biomarker Levels at Week 4
Changes in serum biomarkers potentially associated with autonomic dysfunction and neuroinflammation will be assessed between baseline and Week 4. Serum levels of neuropeptide Y (NPY), interleukin-6 (IL-6), and neurofilament light chain (NFL) will be measured using commercially available ELISA assays.
Time frame: From baseline to the end of Week 4
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score at Week 2
Change from baseline to Week 2 in fibromyalgia-related health status measured using the Revised Fibromyalgia Impact Questionnaire (FIQR). Higher scores indicate greater disease impact and functional impairment. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Widespread Pain Index (WPI) Score at Week 4
Change from baseline to Week 4 in pain distribution measured using the Widespread Pain Index (WPI). Higher scores indicate a greater number of painful body regions. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to end of treatment at Week 4
Change in Symptom Severity Score (SSS) at Week 4
Change from baseline to Week 4 in symptom severity measured using the Symptom Severity Score (SSS). Higher scores indicate greater severity of fibromyalgia-related symptoms. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to end of treatment at Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4
Change from baseline to Week 4 in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to end of treatment at Week 4
Change in Fatigue Severity Scale (FSS) Score at Week 4
Change from baseline to Week 4 in fatigue severity measured using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to end of treatment at Week 4
Change in COMPASS-31 Score at Week 2
Change from baseline to Week 2 in autonomic symptom burden measured using the Composite Autonomic Symptom Score (COMPASS-31). Higher scores indicate greater autonomic symptom severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Widespread Pain Index (WPI) Score at Week 2
Change from baseline to Week 2 in pain distribution measured using the Widespread Pain Index (WPI). Higher scores indicate a greater number of painful body regions. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Symptom Severity Score (SSS) at Week 2
Change from baseline to Week 2 in the Symptom Severity Score (SSS), a measure of the severity of core fibromyalgia symptoms, including fatigue, unrefreshing sleep, cognitive symptoms, and other somatic symptoms. Higher scores indicate greater symptom severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Pittsburgh Sleep Quality Index (PSQI) Score at Week 2
Change from baseline to Week 2 in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Fatigue Severity Scale (FSS) Score at Week 2
Change from baseline to Week 2 in fatigue severity measured using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 2
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score at Week 8
Change from baseline to Week 8 in fibromyalgia-related health status measured using the Revised Fibromyalgia Impact Questionnaire (FIQR). Higher scores indicate greater disease impact and functional impairment. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in COMPASS-31 Score at Week 8
Change from baseline to Week 8 in autonomic symptom burden measured using the Composite Autonomic Symptom Score (COMPASS-31). Higher scores indicate greater autonomic symptom severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in Widespread Pain Index (WPI) Score at Week 8
Change from baseline to Week 8 in pain distribution measured using the Widespread Pain Index (WPI). Higher scores indicate a greater number of painful body regions. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in Symptom Severity Score (SSS) at Week 8
Change from baseline to Week 8 in the Symptom Severity Score (SSS), a measure of the severity of core fibromyalgia symptoms, including fatigue, unrefreshing sleep, cognitive symptoms, and other somatic symptoms. Higher scores indicate greater symptom severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8
Change from baseline to Week 8 in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in Fatigue Severity Scale (FSS) Score at Week 8
Change from baseline to Week 8 in fatigue severity measured using the Fatigue Severity Scale (FSS). Higher scores indicate greater fatigue severity. Questionnaire data will be collected electronically using a REDCap-based application.
Time frame: From baseline to Week 8
Change in Total Heart Rate Variability Power at Week 4
Change from baseline to Week 4 in total heart rate variability power derived from electrocardiogram R-R interval recordings. Total power reflects overall heart rate variability across the analyzed frequency spectrum and is expressed in milliseconds squared (ms²).
Time frame: From baseline to Week 4
Change in Low-Frequency Heart Rate Variability Power at Week 4
Change from baseline to Week 4 in low-frequency heart rate variability power derived from electrocardiogram R-R interval recordings. Low-frequency power is expressed in milliseconds squared (ms²).
Time frame: From Baseline to Week 4
Change in Low-Frequency Heart Rate Variability in Normalized Units at Week 4
Change from baseline to Week 4 in low-frequency heart rate variability expressed in normalized units (LFnu), derived from electrocardiogram R-R interval recordings. Higher values indicate a greater relative contribution of low-frequency oscillations to heart rate variability.
Time frame: From baseline to week 4
Change in LF/HF Ratio at Week 4
Change from baseline to Week 4 in the ratio between low-frequency and high-frequency heart rate variability components (LF/HF ratio), derived from electrocardiogram R-R interval recordings. The LF/HF ratio is a dimensionless measure of sympathovagal balance.
Time frame: From baseline to week 4
Change in Total Heart Rate Variability Power at Week 8
Change from baseline to Week 8 in total heart rate variability power derived from electrocardiogram R-R interval recordings. Total power reflects overall heart rate variability across the analyzed frequency spectrum and is expressed in milliseconds squared (ms²).
Time frame: From baseline to week 8
Change in Low-Frequency Heart Rate Variability Power at Week 8
Change from baseline to Week 8 in low-frequency heart rate variability power derived from electrocardiogram R-R interval recordings. Low-frequency power is expressed in milliseconds squared (ms²).
Time frame: From baseline to week 8
Change in Low-Frequency Heart Rate Variability in Normalized Units at Week 8
Change from baseline to Week 8 in low-frequency heart rate variability expressed in normalized units (LFnu), derived from electrocardiogram R-R interval recordings. Higher values indicate a greater relative contribution of low-frequency oscillations to heart rate variability.
Time frame: From baseline to week 8
Change in LF/HF Ratio at Week 8
Change from baseline to Week 8 in the ratio between low-frequency and high-frequency heart rate variability components (LF/HF ratio), derived from electrocardiogram R-R interval recordings. The LF/HF ratio is a dimensionless measure of sympathovagal balance.
Time frame: from baseline to week 8
Plan to share: Yes — De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding investigator, following publication, for purposes of scientific research and after approval of a methodologically sound proposal.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 6 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding investigator. Data will be shared after approval of the proposal and execution of a data access agreement, in accordance with institutional and ethical regulations.
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
Of 438 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 11 months is below that.
Counting every sponsor, half of 451 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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University of Roma La Sapienza →