Recruiting

NIBS

Sponsor:

Pulkit Grover

Code:

NCT07644221

Conditions

Fibromyalgia (FM)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Primary Motor Cortex Stimulation

Occipital Lobe Stimulation

Study Details

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)

Study ID

NCT07644221

Start date

Sep 9, 2026

Status verified date

Oct, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation

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

experimental: Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation

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

Interventions

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).

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Pulkit Grover, PhD

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

Benedict J Alter, PhD

412-677-0575alterbj@upmc.edu

Locations

UPMC Pain Management

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

Benedict J Alter, MD, PhD

412-677-0575alterbj@upmc.edu

Emma Racunas, BS

ECR79@pitt.edu

More Information

Sponsor

Pulkit Grover

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Pulkit Grover on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.