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NCT Number: NCT07644221

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary Motor Cortex Stimulation

Device

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).

Other names: Transcranial Electrical Stimulation

Occipital Lobe Stimulation

Device

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.

Other names: Transcranial Electrical Stimulation

Primary outcomes

  1. Feasibility of the transcranial electrical stimulation protocol

    Time frame: From 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.

  2. Tolerability of transcranial electrical stimulation protocol

    Time frame: Every 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 (%).

  3. Acceptability of transcranial electrical stimulation protocol

    Time frame: From 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.

  4. Pressure pain threshold (PPT)

    Time frame: 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.

Secondary outcomes

  1. Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: Weekly from enrollment until up to 6 months after the last study session.

    FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment.

  2. Brief Pain Inventory (BPI)

    Time frame: Daily, from enrollment until up to 6 months after the last study session.

    BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Weekly, from enrollment until up to 6 months after the last study session.

    We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed.

Other outcomes

  1. Number of steps

    Time frame: Every day from enrollment until up to 4 weeks after the last study session.

    Assess change in number of steps taken daily using a wearable device.

  2. Active zone minutes

    Time frame: Every day from enrollment until up to 4 weeks after the last study session.

    Assess change in number of minutes spent in active heart rate zone using a wearable device.

  3. Sleep score

    Time frame: Every day from enrollment until up to 4 weeks after the last study session.

    Assess change in sleep quality using a wearable device.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedict J Alter, PhD

CONTACT

[email protected]

412-677-0575

Pulkit Grover, PhD

CONTACT

[email protected]

412-268-3644

Sponsors and collaborators

Lead sponsor

Pulkit Grover

Other

Collaborators

  • Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh
  • University of Pittsburgh Clinical and Translational Science Institute (CTSI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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