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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPulkit Grover

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Primary Motor Cortex Stimulation
  • Occipital Lobe Stimulation

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

2
Carnegie Mellon University15213, PittsburghPennsylvania, United States
UPMC Pain Management15206, PittsburghPennsylvania, United States

Sponsors and collaborators

Pulkit Grover

Lead sponsor

Carnegie Mellon University

Sponsor institution

Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

Collaborator

University of Pittsburgh Clinical and Translational Science Institute (CTSI)

Collaborator