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Fibromyalgia SyndromePRANCIRNCT07525063

Pain & Reward Neuromodulation of CNS Circuits

A study testing Transcranial Magnetic Stimulation (TMS) in people with Fibromyalgia Syndrome and Fibromyalgia, run by Duke University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Transcranial Magnetic Stimulation (TMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
21 Jul 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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)
  2. current hypomania,
  3. meets diagnostic criteria for current psychotic disorder, or psychotic features,
  4. meets diagnostic criteria for Bipolar I disorder,
  5. meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity)
  6. current uncontrolled anorexia or other condition requiring hospitalization,
  7. current serious medical illness, including current severe migraine headaches,
  8. changed psychotropic medications in the prior 2 months, or plans to change medication during the study,
  9. 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),
  10. conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis,
  11. use of investigational drug or devices within 4 weeks of screening,
  12. cochlear implants,
  13. 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the detailed description

This is a study to compare activity in the brains of female adults with chronic pain before and after a new intervention. What the researchers learn by doing this study may help them understand how the brain works and how to develop new and targeted treatments for adults with chronic pain.

Female participants in this study will come to Duke Hospital for up to 6 visits. First, there is an MRI scan visit. Then, there are 4 intervention (TMS) visits, one after the other over 4 days. Next, there is an identical follow up MRI scan visit. Afterwards, there is a one month, three month, and six month follow up that can be completed remotely.

During each of 2 MRI study visits, participants will:

  • Have a urine test for drug use (and pregnancy if applicable)
  • Have a blood draw to measure inflammation and/or genetic testing
  • Have magnetic resonance imaging (MRI) scans of the brain and spine
  • Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires

During each of 4 TMS study visits, participants will:

  • Have brief transcranial magnetic stimulation (TMS) applied to the head
  • Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires

Participation is complete once the requested study visits and follow-up questionnaires have been completed.

Being tested
Transcranial Magnetic Stimulation (TMS)
Keywords
Fibromyalgia, Transcranial Magnetic Stimulation, Neuromodulation, fatigue, cognitive issues, fibro fog, brain fog, trouble sleeping, AFSA, Fibromyalgia Syndrome, pain
Medical subject headings
Fibromyalgia, Chronic Pain, Fatigue, Mental Fatigue, Parasomnias, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic Stimulation (TMS)Device

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

Study groups in NCT07525063
Study groupRoleWhat they receive
Active TMSExperimentalParticipants receive TMS over 4 consecutive days (20 sessions total).
Receives: Device: Transcranial Magnetic Stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)

  1. Change in the brain's response to task stimuli

    Functional Magnetic Resonance Imaging (fMRI) will be used to track blood-oxygen-level-dependent (BOLD) signals during reward anticipation and feedback. BOLD signal change identifies neural activity in the brain which will be reported as normalized to percent signal change (Avg%Δ) relative to the mean image intensity to allow for cross-subject comparison (i.e., arbitrary units scale).

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

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

    Functional connectivity in fMRI measures the statistical dependencies (similarities) between blood oxygen level-dependent (BOLD) signal time series from different brain regions. Typically quantified using Pearson's correlation or covariance in either resting-state or task-based studies, it identifies synchronized activity indicating functionally linked regions/networks.

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

  3. Ventral-dorsal spinal cord fMRI-indicated activity

    Amplitude of Low-Frequency Fluctuations (ALFF) in fMRI measures the intensity of spontaneous brain activity by calculating the square root of the power spectrum (via Fast Fourier Transform) within a specific low-frequency range. It quantifies the amplitude of resting-state BOLD signal oscillations, typically after voxel-wise standardization (i.e., arbitrary units scale).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start21 Jul 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07525063
Sponsor's protocol ID
Pro00118676
Acronym
PRANCIR
Status last verified
Jul 2026
First submitted
6 Apr 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: As this is a small feasibility trial and will not be published, we do not plan to share the data.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation (TMS) in people with Fibromyalgia Syndrome and Fibromyalgia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07525063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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