Fibromyalgia (FM)NCT07644221
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
A study testing Primary Motor Cortex Stimulation and Occipital Lobe Stimulation in people with Fibromyalgia (FM), run by Pulkit Grover at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Primary Motor Cortex Stimulation and Occipital Lobe Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC Pain Management
Pittsburgh, Pennsylvania, 15206
Benedict J Alter, MD, PhD, 412-677-0575, alterbj@upmc.edu
Emma Racunas, BS, ECR79@pitt.edu
- Not yet recruiting
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
Pulkit Grover, PhD, 412-268-3644, pgrover@andrew.cmu.edu
Jeehyun Kim, MS, 248-619-4271, jeehyunk@andrew.cmu.edu
About this study
Official title: Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain
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.
Read the 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.
- Conditions
- Fibromyalgia (FM)
- Being tested
- Primary Motor Cortex Stimulation, Occipital Lobe Stimulation
- Keywords
- Transcranial Electrical Stimulation, Noninvasive Brain Stimulation, Fibromyalgia, Chronic Pain, Pulsed Transcranial Electrical Stimulation
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Motor Cortex StimulationDevice
Also called Transcranial Electrical 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).
Occipital Lobe StimulationDevice
Also called Transcranial Electrical 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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation | Experimental | The primary motor cortex will be targeted first, then the occipital lobe. Receives: 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. Receives: Device: Primary Motor Cortex Stimulation; Device: Occipital Lobe Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: At every study session from Session 1 until the last study session.
Secondary outcomes (3)
Revised Fibromyalgia Impact Questionnaire (FIQR)
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.
Measured: Weekly from enrollment until up to 6 months after the last study session.
Brief Pain Inventory (BPI)
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.
Measured: Daily, from enrollment until up to 6 months after the last study session.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
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.
Measured: Weekly, from enrollment until up to 6 months after the last study session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulkit Grover
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh, University of Pittsburgh Clinical and Translational Science Institute (CTSI)
- Responsible party
- Sponsor-investigator, Pulkit Grover, Carnegie Mellon University
- Investigators
- Pulkit Grover, PhD, Principal investigator, Carnegie Mellon UniversityBenedict J Alter, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644221
- Sponsor's protocol ID
- STUDY2025_00000279
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared upon reasonable request to the study contacts.