NCT07644221

Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
Pulkit Grover
~50 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Primary Motor Cortex StimulationOccipital Lobe Stimulation

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of the transcranial electrical stimulation protocol
Measured over From end of the last study session until up to 6 months after.
+3 more outcomes measured
Fibromyalgia (FM)
2 sites across 1 states
Pennsylvania2
  • Pulkit Grover, PhD · PRINCIPAL_INVESTIGATOR · Carnegie Mellon University
  • Benedict J Alter, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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Eligibility criteria

Inclusion

Formal diagnosis of fibromyalgia made by a practicing physician
Pain resistant to common analgesics and medications for chronic pain
Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)
Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.

Exclusion

If the subject is non-ambulatory.
If the subject is female of child-bearing potential, subject must not be pregnant.
Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.
Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.
Subject must not have any implanted electronic or metallic devices.
Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV/AIDS).
  • Feasibility of the transcranial electrical stimulation protocolFrom end of the last study session until up to 6 months after.

    Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews.

  • Tolerability of transcranial electrical stimulation protocolEvery day from enrollment until up to 6 months after the last study session.

    Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%).

  • Acceptability of transcranial electrical stimulation protocolFrom end of the last study session until up to 6 months after.

    Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews.

  • Pressure pain threshold (PPT)At every study session from Session 1 until the last study session.

    PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study.