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

Official title

Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain

Overview

The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are: Do repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life? Researchers will compare different brain targets to see if effects are different between them. Participants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.

Detailed description

Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session)

NIBS administration will consist of 1000 electrical pulses of \<1 ms duration each.

Interventions

• Device Primary Motor Cortex Stimulation
  Short (\<1 ms), high amplitude (\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
• Device Occipital Lobe Stimulation
  Short (\<1 ms), high amplitude (\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.

Primary outcome measures

• Feasibility of the transcranial electrical stimulation protocol [Time frame: From end of the last study session until up to 6 months after.]
• Tolerability of transcranial electrical stimulation protocol [Time frame: Every day from enrollment until up to 6 months after the last study session.]
• Acceptability of transcranial electrical stimulation protocol [Time frame: From end of the last study session until up to 6 months after.]
• Pressure pain threshold (PPT) [Time frame: At every study session from Session 1 until the last study session.]

Secondary outcome measures (3)

• Revised Fibromyalgia Impact Questionnaire (FIQR) [Time frame: Weekly from enrollment until up to 6 months after the last study session.]
• Brief Pain Inventory (BPI) [Time frame: Daily, from enrollment until up to 6 months after the last study session.]
• Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Time frame: Weekly, from enrollment until up to 6 months after the last study session.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• UPMC Pain Management — Pittsburgh
• Carnegie Mellon University — Pittsburgh

Identifiers

NCT: NCT07644221 · STUDY2025_00000279

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗