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Behavioural Intervention

Brain Stimulation for Fibromyalgia

N/A
Recruiting
Led By Richard Harris, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mean recalled pain over the last seven days (7-day recall) greater than or equal to 3 on a 10 centimeter (cm) Visual Analog Scale (VAS) for pain; 7-day recall
Fibromyalgia participants must satisfy the American College of Rheumatology (2011) survey criteria for the classification of Fibromyalgia (FM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32)
Awards & highlights

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.

Who is the study for?
This trial is for adults with fibromyalgia experiencing pain most days, and healthy right-handed controls with minimal pain. Participants must be able to visit the study site regularly and not start new treatments during the study. Exclusions include severe psychiatric illnesses, certain medical conditions like autoimmune diseases, knowledge of HD-tDCS that could bias results, or safety risks for brain stimulation or imaging.Check my eligibility
What is being tested?
The trial examines how a type of brain activity called explosive synchronization relates to chronic pain in fibromyalgia. It tests whether targeted non-invasive brain stimulation (HD-tDCS) can alter this activity and reduce pain. The study includes assessments using EEG and fMRI neuroimaging before and after sham or actual HD-tDCS treatment.See study design
What are the potential side effects?
Possible side effects from HD-tDCS may include mild discomfort at the electrode sites on the scalp, itching, tingling sensations during treatment, fatigue, headache or nausea post-treatment. Neuroimaging is generally safe but may cause discomfort due to loud noises in MRI or claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My average pain level in the past week was 3 or more on a scale of 10.
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I have been diagnosed with Fibromyalgia according to the 2011 criteria.
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My average pain level over the last week was 3 or more on a scale of 10.
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I have experienced pain on most days for the last month.
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My pain is almost non-existent based on a recent pain scale.
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I can travel to the study site for treatments 5 times a week.
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I can go to the clinic 5 times a week for HD-tDCS treatments.
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I have had fibromyalgia pain most days for the last month.
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I have been diagnosed with Fibromyalgia according to the 2011 criteria.
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My average pain level over the last week is 3 or more on a scale of 10.
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My average pain in the last week was 3 or more on a scale of 10.
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I agree not to start new treatments for fibromyalgia during the study.
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I have experienced pain on most days for the last month.
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I can understand and sign the consent form.
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I have had fibromyalgia pain on most days for the last month.
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I barely feel pain, scoring it below 0.5 out of 10.
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I barely feel any pain, scoring it below 0.5 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 8 (approximately day 14- day18), visit 14 (approximately day 28-32) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apolipoprotein E
Aim 3 - Change in brain EEG metrics of ES: Change from visit 8 to visit 14 in correlation of EEG alpha band degree and frequency.
Secondary outcome measures
Aim 1: Insular Glx (glutamate + glutamine) using proton magnetic resonance spectroscopy obtained at Visit 2
Aim 1: Resting brain functional connectivity using functional magnetic resonance imaging obtained at Visit 2
Body Weight Changes
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Aim 3- HD-tDCS of ESExperimental Treatment4 Interventions
There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
Group II: Aim 3 - HD-tDCS of M1Experimental Treatment4 Interventions
There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
Group III: Aim 1 - Healthy controlExperimental Treatment2 Interventions
Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures.
Group IV: Aim 1 - Fibromyalgia participantExperimental Treatment2 Interventions
Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures.
Group V: Aim 3 - ShamPlacebo Group4 Interventions
There will be two weeks of treatment in which participants will have 5 daily sessions of focused HD-tDCS or Sham per week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EEG
2013
N/A
~3530

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,372 Total Patients Enrolled
15 Trials studying Fibromyalgia
1,371 Patients Enrolled for Fibromyalgia
National Center for Complementary and Integrative Health (NCCIH)NIH
829 Previous Clinical Trials
668,779 Total Patients Enrolled
16 Trials studying Fibromyalgia
1,193 Patients Enrolled for Fibromyalgia
Richard Harris, PhD4.29 ReviewsPrincipal Investigator - University of Michigan
Northwestern Memorial Hospital
Medical School - Loyola University Chicago, Doctor of Medicine
San Mateo Community Mental Health Services, Residency in Psychiatry
2 Previous Clinical Trials
221 Total Patients Enrolled
2Patient Review
Unfortunately, this physician didn't work out for me. Though, I will say, they were a great listener.

Media Library

HD-tDCS treatments (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04606095 — N/A
Fibromyalgia Research Study Groups: Aim 1 - Fibromyalgia participant, Aim 3 - HD-tDCS of M1, Aim 3- HD-tDCS of ES, Aim 1 - Healthy control, Aim 3 - Sham
Fibromyalgia Clinical Trial 2023: HD-tDCS treatments Highlights & Side Effects. Trial Name: NCT04606095 — N/A
HD-tDCS treatments (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606095 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have Fibromyalgia. It affects me every day. I am no longer able to work or enjoy many things I have in the past.
PatientReceived 1 prior treatment
I’ve tried SSRI, pregablin, meditation, and only cardio exercise plans as prescribed. I just want a chance at a semi “normal” life where I am not as tired and can exercise as normal.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~47 spots leftby Oct 2025