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Enrolling by invitationNo phase

Pain & Reward Neuromodulation of CNS Circuits

Key facts

Who runs it
Duke University
Where
Durham, United StatesSee the site
Trial code
Status
Enrolling by invitation
People taking part
30 people, planned
Started
21 Jul 2026
Expected to end
Jun 2027
Type of study
Interventional
Treatments tested
  • Transcranial Magnetic Stimulation (TMS)
Record updated
28 July 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Other criteria

  • Inclusions:
  • Female and ages 18 +
  • Ability to read/understand English and give consent to participate
  • Physician diagnosis \& confirmation of primary fibromyalgia syndrome
  • 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
  • If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study
  • Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime); Exclusions:
  • limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)
  • MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)
  • 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)
  • male *; TMS-Specific Exclusions:
  • TMS contraindication (e.g., history of seizures, medications contraindicated for risks/efficacy of TMS procedures)
  • current hypomania,
  • meets diagnostic criteria for current psychotic disorder, or psychotic features,
  • meets diagnostic criteria for Bipolar I disorder,
  • meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity)
  • current uncontrolled anorexia or other condition requiring hospitalization,
  • current serious medical illness, including current severe migraine headaches,
  • changed psychotropic medications in the prior 2 months, or plans to change medication during the study,
  • 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),
  • conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis,
  • use of investigational drug or devices within 4 weeks of screening,
  • cochlear implants,
  • 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

Where in United States

  • Duke University Medical CenterDurham, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Active TMSTreatment being tested

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

    Treatment: Transcranial Magnetic Stimulation (TMS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
28 July 2026