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Pain & Reward Neuromodulation of CNS Circuits

Pain & Reward Neuromodulation of CNS Circuits

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07525063
Acronym
PRANCIR
Enrollment
30
Registered
2026-04-13
Start date
2026-07-21
Completion date
2027-06-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain and Fatigue, Fibromyalgia, Fibromyalgia Syndrome

Keywords

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

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.

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.

Interventions

DEVICETranscranial Magnetic Stimulation (TMS)

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

Sponsors

Duke University
Lead SponsorOTHER
American Fibromyalgia Syndrome Association
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain IntensityBaseline MRI and post-intervention MRI (approximately 3 weeks)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).
Change in FatigueBaseline MRI and post-intervention MRI (approximately 3 weeks)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.
Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)Baseline MRI and post-intervention MRI (approximately 3 weeks)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.

Secondary

MeasureTime frameDescription
Change in the brain's response to task stimuliBaseline MRI and post-intervention MRI (approximately 3 weeks)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).
Change in the brain's cortico-striatal circuit functional connectivityBaseline MRI and post-intervention MRI (approximately 3 weeks)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.
Ventral-dorsal spinal cord fMRI-indicated activityBaseline MRI and post-intervention MRI (approximately 3 weeks)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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine T Martucci, PhD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026