Noninvasive brain stimulation to see if it lowers pain in fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores whether noninvasive brain stimulation (NIBS) can alter pain perception in fibromyalgia. Participants receive daily NIBS sessions over four weeks, with pain testing and quality-of-life questionnaires. In a randomized crossover design, they receive stimulation to the primary motor cortex and to the occipital lobe in different periods, separated by a washout. Each session includes pressure pain measurements and up to five hours of assessments to track symptom changes and well-being. The study uses brief electrical pulses to stimulate targeted brain regions and compares effects between brain targets.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• UPMC Pain Management
  Pittsburgh, Pennsylvania, United States Recruiting
• Carnegie Mellon University
  Pittsburgh, Pennsylvania, United States Not yet recruiting

Study contacts

• Principal investigator: Pulkit Grover, PhD — Carnegie Mellon University
• Study coordinator: Pulkit Grover, PhD
• Email: pgrover@andrew.cmu.edu
• Phone: 412-268-3644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.