Pain & Reward Neuromodulation of CNS Circuits

NCT07525063 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00118676
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.

Conditions

Fibromyalgia Syndrome; Fibromyalgia; Chronic Pain and Fatigue

Keywords

Fibromyalgia; Transcranial Magnetic Stimulation; Neuromodulation; fatigue; cognitive issues; fibro fog; brain fog; trouble sleeping; AFSA; Fibromyalgia Syndrome; pain

Outcome Measures

Primary Outcomes (3)

• Change in Pain Intensity

  PROMIS Short Form - Pain Intensity (3a) is a 3-item measure which includes questions of pain at its worst (past 7 days), average pain (past 7 days), and pain right now (at time of survey). Each item is rated from No Pain (1) to Very Severe (5).

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• Change in Fatigue

  The PROMIS Fatigue Computer Adaptive Test (CAT) is a dynamic, patient-reported outcome tool that measures fatigue severity (intensity, frequency, and impact) over the past seven days. Using item response theory (IRT), it selects the next best question based on previous answers, typically requiring only 4-6 items to produce highly precise, reliable scores while minimizing patient burden. Scoring: Results are reported as T-scores, where 50 is the general population mean and 10 is the standard deviation. A T-score of 60 or higher is one standard deviation worse than average.

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)

  The Montreal Cognitive Assessment (MoCA) is a valid, 30-point screening tool used to assess "fibro fog"-the cognitive dysfunction, memory loss, and attention difficulties associated with fibromyalgia. Scoring: The test is scored out of 30 points. A score of 26-30 is considered normal, while scores below 26 may indicate mild cognitive impairment (19-25) or more advanced impairment (below 21). One point is added for individuals with 12 years or fewer of formal education.

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

Secondary Outcomes (3)

• Change in the brain's response to task stimuli

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• Change in the brain's cortico-striatal circuit functional connectivity

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• Ventral-dorsal spinal cord fMRI-indicated activity

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

Other Outcomes (3)

• Blood cytokine levels

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• PEG Scale Change

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

• Fibromyalgia Impact Questionnaire (FIQ-R) Change

  Baseline MRI and post-intervention MRI (approximately 3 weeks)

Study Arms (1)

Active TMS

EXPERIMENTAL

Participants receive TMS over 4 consecutive days (20 sessions total).

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

TMS protocol delivered via MagPro X100 stimulator with figure-8 coil targeting prefrontal cortex.

Active TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusions: 1. Female and ages 18 + 2. Ability to read/understand English and give consent to participate 3. Physician diagnosis \& confirmation of primary fibromyalgia syndrome 4. Verbal agreement to maintain dose of prescribed medication (if any) constant throughout the study, except exclusion medication and except if there is a medical emergency requiring changes in medication 5. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study 6. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime) Exclusions: 1. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months) 2. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant) 3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications) 4. male \* TMS-Specific Exclusions: 1\. TMS contraindication (e.g., history of seizures, medications contraindicated for risks/efficacy of TMS procedures) 1. current hypomania, 2. meets diagnostic criteria for current psychotic disorder, or psychotic features, 3. meets diagnostic criteria for Bipolar I disorder, 4. meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity) 5. current uncontrolled anorexia or other condition requiring hospitalization, 6. current serious medical illness, including current severe migraine headaches, 7. changed psychotropic medications in the prior 2 months, or plans to change medication during the study, 8. history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), 9. conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis, 10. use of investigational drug or devices within 4 weeks of screening, 11. cochlear implants, 12. pregnancy * Only females will be enrolled in this study because it focuses on patients who have fibromyalgia which is more prevalent (both diagnosed and self-reported) in females. Due to the contributions of hormones to the conditions under study in this project, female eligibility in this study will be defined as an individual who is female sex at birth and currently female sex

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• American Fibromyalgia Syndrome Association: collaborator

Related Links

• Martucci Lab Website

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Fatigue; Mental Fatigue; Parasomnias; Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Katherine T Martucci, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martucci Lab Clinical Research Specialist

CONTACT

919-684-3161; ChronicPainResearch@duke.edu

Darius Williams

CONTACT

919-684-2758; ladarius.williams@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share