Trial · NCT07904351
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
NCT07904351, Not applicable, Not yet recruiting, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation. Trials, record NCT07904351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
- NCT number
- NCT07904351
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 105 participants, estimated
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Fibromyalgia
- Interventions
- Transcutaneous Vagus Nerve Stimulation
- First posted
- 2026-10-29
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Score | Week 0 and Week 6 | The SF-MPQ-2 assesses pain quality and intensity across multiple pain domains and includes a general pain intensity rating. Participants rate pain severity on a scale from 0 (none) to 10 (worst possible). Higher scores indicate greater pain severity. |
| Secondary | Multidimensional Fatigue Inventory | Week 0 and Week 6 | The Multidimensional Fatigue Inventory (MFI-20) is a 20-item self-report questionnaire that assesses general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Participants rate statements using a 5-point Likert scale. Higher total scores indicate greater fatigue. |
| Secondary | Revised Fibromyalgia Impact Questionnaire (FIQR) Total Score | Week 0 and Week 6 | The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item self-report measure assessing fibromyalgia-related function, overall impact, and symptoms during the previous 7 days. Total scores range from 0 to 100, with higher scores indicating greater fibromyalgia symptom burden and functional impairment. |
| Secondary | Supplemental Gastrointestinal Symptom Questionnaire Score | Week 0 and Week 6 | The Supplemental Gastrointestinal Symptom Questionnaire assesses gastrointestinal symptoms, including abdominal pain, bloating, abnormal bowel movements, irritable bowel syndrome diagnosis, and stool characteristics. Higher scores indicate greater gastrointestinal symptom burden. |
| Secondary | Empirical Dietary Inflammatory Index (EDII) Score | Week 0 and Week 6 | The Empirical Dietary Inflammatory Index (EDII) is a dietary assessment questionnaire that evaluates the inflammatory potential of dietary intake based on the frequency of consumption of specific food and beverage categories. Higher scores indicate a more pro-inflammatory dietary pattern. |
| Secondary | Medical Outcomes Study Questionnaire Short Form 36 (SF-36) | Week 0 and Week 6 | The SF-36 is a 36-item self-report measure of health-related quality of life assessing physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Higher scores indicate better health status and quality of life. |
| Secondary | Medical Outcomes Study (MOS) Sleep Scale Score | Week 0 and Week 6 | The MOS Sleep Scale is a 12-item self-report questionnaire that assesses sleep disturbance, sleep adequacy, daytime somnolence, sleep quantity, and other sleep-related problems experienced during the previous 4 weeks. Higher scores indicate greater sleep disturbance and poorer sleep quality. |
| Secondary | Blood inflammation marker | Week 0 and Week 6 | Collect blood samples for cytokine level assessment. |
| Secondary | Assessment of Gut Microbiome Changes Through Genomic and Phenotypic Analysis | Week 0 and Week 6 | Collect stool samples to analyze bacterial composition and metabolomic profiles of the gut microbiome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R61AR086955 | Toward Biomarker-Guided Fibromyalgia Treatment with Non-Invasive Vagus Nerve Stimulation | Chen, Lucy L. | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904351
GET https://conductscience.org/api/trials/v1/NCT07904351/registered