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

NCT07644221 | Not Yet Recruiting

• 1 other identifier: STUDY2025_00000279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fibromyalgia (FM)

Keywords

Transcranial Electrical Stimulation; Noninvasive Brain Stimulation; Fibromyalgia; Chronic Pain; Pulsed Transcranial Electrical Stimulation

Outcome Measures

Primary Outcomes (4)

• Feasibility of the transcranial electrical stimulation protocol

  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.

  From end of the last study session until up to 6 months after.

• Tolerability of transcranial electrical stimulation protocol

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

  Every day from enrollment until up to 6 months after the last study session.

• Acceptability of transcranial electrical stimulation protocol

  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.

  From end of the last study session until up to 6 months after.

• Pressure pain threshold (PPT)

  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.

  At every study session from Session 1 until the last study session.

Secondary Outcomes (3)

• Revised Fibromyalgia Impact Questionnaire (FIQR)

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

• Brief Pain Inventory (BPI)

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

• Patient-Reported Outcomes Measurement Information System (PROMIS-29)

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

Other Outcomes (3)

• Number of steps

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

• Active zone minutes

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

• Sleep score

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

Study Arms (2)

Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation

EXPERIMENTAL

The primary motor cortex will be targeted first, then the occipital lobe.

Device: Primary Motor Cortex Stimulation; Device: Occipital Lobe Stimulation

Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation

EXPERIMENTAL

The occipital lobe will be targeted first, then the primary motor cortex.

Device: Primary Motor Cortex Stimulation; Device: Occipital Lobe Stimulation

Interventions

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).

Also known as: Transcranial Electrical Stimulation

Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation; Primary Motor Cortex Stimulation, then Occipital Lobe 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.

Also known as: Transcranial Electrical Stimulation

Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation; Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pulkit Grover: lead
• Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh: collaborator
• University of Pittsburgh Clinical and Translational Science Institute (CTSI): collaborator

Study Sites (2)

UPMC Pain Management

Pittsburgh, Pennsylvania, 15206, United States

Location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Pulkit Grover, PhD

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

• Benedict J Alter, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pulkit Grover, PhD

CONTACT

412-268-3644; pgrover@andrew.cmu.edu

Benedict J Alter, PhD

CONTACT

412-677-0575; alterbj@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after publication per journal and funding entity protocols.
• Access Criteria: Data will be made available by reasonable request and/or per journal and funding entity protocols.

Locations

US (2)