Noninvasive Brain Stimulation for Fibromyalgia

Not yet recruiting at 1 trial location
PG
BJ
Overseen ByBenedict J Alter, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pulkit Grover
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether noninvasive brain stimulation (NIBS) can reduce pain and improve the quality of life for individuals with fibromyalgia, a condition causing widespread pain and fatigue. Participants will undergo repeated sessions targeting different brain areas, including Occipital Lobe Stimulation and Primary Motor Cortex Stimulation, to determine the most effective approach. The study seeks individuals diagnosed with fibromyalgia who experience ongoing pain not relieved by standard pain medications and have had this pain for more than three months. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could potentially enhance quality of life.

What prior data suggests that noninvasive brain stimulation is safe for fibromyalgia?

Research shows that stimulating the occipital lobe and the primary motor cortex is generally safe for treating fibromyalgia.

For occipital lobe stimulation, studies have found it can significantly reduce pain for people with fibromyalgia. One study reported a 39.74% decrease in pain intensity on a visual scale, with no serious side effects, indicating the treatment is well-tolerated.

Researchers have also examined primary motor cortex stimulation for safety and effectiveness. Studies show it can lower pain scores without major side effects. Some research notes improvements in overall fibromyalgia symptoms with this treatment.

Overall, both stimulation methods appear to be safe options for managing fibromyalgia pain based on past research.12345

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for fibromyalgia, such as medications and physical therapy, these new approaches use noninvasive brain stimulation. Researchers are excited about targeting the brain itself by stimulating the occipital lobe and primary motor cortex, which could offer relief without the side effects of drugs. This method directly influences brain activity, potentially providing faster and more effective pain relief. By using this innovative technique, scientists aim to uncover new ways to manage fibromyalgia symptoms that go beyond the limitations of existing options.

What evidence suggests that this trial's treatments could be effective for fibromyalgia?

Research has shown that stimulating the primary motor cortex can help reduce pain in people with chronic pain and fibromyalgia. Studies have found that this method leads to noticeable drops in pain levels and improved quality of life, with more than half of the patients experiencing less pain after several sessions. In this trial, one group will receive Primary Motor Cortex Stimulation followed by Occipital Lobe Stimulation.

For stimulating the occipital lobe, studies suggest it can also significantly lower pain in fibromyalgia patients, with some trials reporting nearly a 40% reduction in pain, as measured by a simple scale. Another group in this trial will receive Occipital Lobe Stimulation followed by Primary Motor Cortex Stimulation. Both methods show promise for managing pain related to fibromyalgia.12346

Who Is on the Research Team?

PG

Pulkit Grover, PhD

Principal Investigator

Carnegie Mellon University

BJ

Benedict J Alter, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with fibromyalgia who experience chronic pain. Participants should be able to attend daily sessions over four weeks and complete questionnaires. People with certain medical or neurological conditions may not be eligible.

Inclusion Criteria

My pain does not improve with standard pain medications.
I have been formally diagnosed with fibromyalgia by a doctor.
I have had moderate to severe pain for over 3 months.
See 1 more

Exclusion Criteria

I am unable to walk or move around on my own.
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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeated daily sessions of NIBS over 4 weeks, targeting the primary motor cortex and occipital lobe, with pressure pain algometry and questionnaires

4 weeks
Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain perception and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Occipital Lobe Stimulation
  • Primary Motor Cortex Stimulation

Trial Overview

The study tests whether noninvasive brain stimulation, targeting either the primary motor cortex or occipital lobe, can reduce pain and improve quality of life in people with fibromyalgia. Participants receive daily treatments for four weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Primary Motor Cortex Stimulation, then Occipital Lobe StimulationExperimental Treatment2 Interventions
Group II: Occipital Lobe Stimulation, then Primary Motor Cortex StimulationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pulkit Grover

Lead Sponsor

University of Pittsburgh Clinical and Translational Science Institute (CTSI)

Collaborator

Trials
1
Recruited
40+

Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

Collaborator

Citations

The effects of transcranial direct-current stimulation (tDCS) on ...

Clinical and experimental studies suggest that rTMS may reduce pain in FM patients by modulating neural pain pathways, the right temporal lobe

The effect of occipital nerve field stimulation ... - Springer Nature

Recently, occipital nerve field stimulation (ONS) has been proposed as an effective potential treatment for fibromyalgia-related pain. The aim ...

NCT00917176 | Occipital Nerve Stimulation in Fibromyalgia

The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain.

Efficacy and safety of transcranial direct current stimulation ...

This meta-analysis of twenty studies found that tDCS can reduce pain, relieve depression, and reduce the impact of FM.

Fibromyalgia Treated with Occipital Nerve Stimulation

Studies investigating the effect of occipital nerve stimulation for fibromyalgia have shown significant decreases in pain visual analog scale ...

Brain Modulation by Electric Currents in Fibromyalgia

Principal aim of the present paper was to perform a structured review concerning evidence on tES treatment for fibromyalgia with particular ...