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Brain Stimulation for Fibromyalgia
Study Summary
This trial is testing a possible treatment for fibromyalgia that involves stimulating certain areas of the brain. The study will compare brain activity and responses to pain in people with and without fibromyalgia, as well as in people with fibromyalgia who receive different types of brain stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I do not use opioids or marijuana daily and have no history of substance abuse.My average pain level in the past week was 3 or more on a scale of 10.Healthy participants must be right-handed.I will not take OTC pain meds on the day of my EEG/MRI.I don't use opioids, marijuana daily, or have a history of substance abuse.I am not familiar with HD-tDCS techniques for fibromyalgia treatment.Healthy participants should not meet the specific criteria for fibromyalgia according to the American College of Rheumatology.I have been diagnosed with Fibromyalgia according to the 2011 criteria.My average pain level over the last week was 3 or more on a scale of 10.I have fibromyalgia and have never had a severe head injury.People with fibromyalgia must be right-handed.I agree not to start new treatments for my FM symptoms during the study.I have experienced pain on most days for the last month.My pain is almost non-existent based on a recent pain scale.I can travel to the study site for treatments 5 times a week.I can go to the clinic 5 times a week for HD-tDCS treatments.I have fibromyalgia without severe nerve pain affecting my daily activities.I have had fibromyalgia pain most days for the last month.I have never had vascular surgery on my legs and do not have current leg vascular problems.I have been diagnosed with Fibromyalgia according to the 2011 criteria.I have never had a head injury that made me lose consciousness significantly.I have fibromyalgia and no history of vascular surgery or issues in my legs.My average pain level over the last week is 3 or more on a scale of 10.You meet the specific criteria for diagnosing fibromyalgia set by the American College of Rheumatology in 2011.I am willing and able to give written consent for a fibromyalgia study.I haven't taken any as-needed opioid painkillers in the last 48 hours.I haven't taken any over-the-counter pain meds today.I have no health issues that prevent me from having an EEG or MRI.I haven't taken any as-needed opioid painkillers for 48 hours before my brain scan.People with fibromyalgia must not have any conditions that might make it unsafe to use HD-tDCS.Participants with fibromyalgia cannot be involved in legal settlements or receiving money related to their fibromyalgia.My average pain in the last week was 3 or more on a scale of 10.You are right-handed.I have fibromyalgia without any other autoimmune or inflammatory diseases causing pain.I have fibromyalgia and do not suffer from severe mental health issues or recent substance abuse.I agree not to start new treatments for fibromyalgia during the study.You are right-handed.I don't have metal implants or certain dental materials that would interfere with brain scans or electrical stimulation treatments.You are right-handed.I have experienced pain on most days for the last month.Healthy control participants must use their right hand for tasks.People with fibromyalgia must be right-handed.I do not have any long-term illnesses or mental health conditions.I can understand and sign the consent form.I do not have nerve damage that affects my daily activities.I have had fibromyalgia pain on most days for the last month.I barely feel pain, scoring it below 0.5 out of 10.I barely feel any pain, scoring it below 0.5 out of 10.
- Group 1: Aim 1 - Fibromyalgia participant
- Group 2: Aim 3 - HD-tDCS of M1
- Group 3: Aim 3- HD-tDCS of ES
- Group 4: Aim 1 - Healthy control
- Group 5: Aim 3 - Sham
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there currently any available openings for participants?
"Confirmed, according to clinicaltrials.gov the research study is currently in search of volunteers. This trial was first advertised on November 13th 2020 and has been revised as recently as September 21st 2022. A total of 150 individuals are needed for this single-site experiment."
Does this research endeavor include elderly individuals as participants?
"This clinical trial requires participants to be 19 years old or older and no more than 74. There are 88 vacancies available for minors while 790 spots are allocated to those over the age of 65."
Does my medical profile qualify me to join this clinical research?
"This trial is actively seeking 150 participants, aged 19-74 years old, who live with fibromyalgia. Additionally, they must meet the American College of Rheumatology's (2011) survey criteria for FM classification; have experienced pain for over 50% of days in the last month and score at least 3/10 on a visual analog scale when recalling their average level of pain; be able to attend treatments five times per week at the study site; comprehend all study protocols and willingly provide written consent to participate; report minimal levels of pain upon recall on a 10cm VAS measure (<0.5); as well as abstain"
What is the aggregate number of individuals involved in this experiment?
"Affirmative. Clinicaltrials.gov displays evidence that this trial is actively seeking out participants since it was first published on November 13th 2020 and last updated on September 21st 2022. The study necessitates 150 individuals to be enrolled from 1 particular location."
What is the purpose of this clinical research?
"This medical trial, which will be assessed from Day 14 to 18 and then again on Days 28-32, has two main objectives. The first is to evaluate the correlation between EEG alpha band degree and frequency at Visit 1. Secondary goals involve a change in insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy from visit 8 to visit 14, as well as changes in resting brain functional connectivity using functional magnetic resonance imaging from visit 8 &14. Lastly there is an aim for assessing resting brain functional connectivity when utilizing fMRI at Visit 2 with both seed based and independent component analysis."
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