Fibromyalgia Trial, Recruiting NCT04606095 Sponsor: University of Michigan Condition: Fibromyalgia
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Fibromyalgia Trial, Recruiting

NCT04606095
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with fibromyalgia:

  • A doctor has confirmed a fibromyalgia diagnosis using the 2011 American College of Rheumatology classification criteria
  • Pain has been present on more than half of days during the past month
  • Average pain over the past 7 days has been rated at least 3 out of 10 on a pain scale
  • Willingness to avoid starting new medications or treatments for fibromyalgia during the study
  • Being right-handed
  • Able to travel to the study site to receive brain stimulation treatments five times per week
  • Willingness and ability to complete all study procedures
  • Able to give written informed consent

For healthy volunteers (comparison group):

  • Being right-handed
  • Pain rated less than 0.5 out of 10 on a pain scale over the past 7 days
  • Willingness and ability to complete all study procedures
  • Able to give written informed consent

Who may not be able to join:

For people with fibromyalgia:

  • Having another autoimmune or inflammatory condition (such as rheumatoid arthritis or lupus) that also causes pain
  • A history of head injury involving significant loss of consciousness
  • Having nerve damage from a known cause that interferes with everyday activities
  • Daily use of opioid painkillers or marijuana, or a history of substance abuse
  • Currently taking stimulant medications such as those used for ADHD (for example, Adderall, methylphenidate) or wakefulness medications such as modafinil
  • Currently taking part in another treatment trial
  • Taking over-the-counter pain medications (such as anti-inflammatories) on the day of brain or imaging scans
  • Having taken opioid painkillers within 48 hours before a brain or imaging scan
  • Currently pregnant or breastfeeding (a pregnancy test will be done before scan sessions)
  • Having a serious psychiatric illness such as active schizophrenia, major depression with thoughts of suicide, or substance abuse within the past two years
  • Having metal implants, surgical clips, staples, or certain dental metalwork that would make brain stimulation or scanning unsafe
  • Having detailed prior knowledge of the brain stimulation technique used in this trial, or having previously received this type of treatment, in a way that could affect study blinding
  • Having any other factor that the study team determines would prevent safe or reliable participation in the study
  • A history of vascular surgery on the lower limbs, or current circulation problems in the lower limbs
  • Currently involved in workers' compensation claims, legal action, disability claims, out-of-court settlements, or receiving financial compensation related to fibromyalgia
  • Unwillingness or inability to give written informed consent

For healthy volunteers:

  • Meeting the criteria for a fibromyalgia diagnosis
  • Having any ongoing medical condition, including psychiatric disorders such as psychosis or schizophrenia (based on self-report)
  • A history of head injury involving significant loss of consciousness
  • Having nerve damage from a known cause that interferes with everyday activities
  • Daily use of opioid painkillers or marijuana, or a history of substance abuse
  • Currently taking stimulant medications such as those used for ADHD, or wakefulness medications such as modafinil
  • Currently taking part in another treatment trial
  • Currently pregnant or breastfeeding (a pregnancy test will be done before scan sessions)
  • Having metal implants or other factors that would make brain or imaging scans unsafe
  • Taking over-the-counter pain medications on the day of a scan
  • Having taken opioid painkillers within 48 hours before a scan
  • A history of substance use disorder in the past 24 months (based on self-report)
  • A history of vascular surgery on the lower limbs, or current circulation problems in the lower limbs
  • Any other factor that the study team determines would prevent satisfactory completion of the study
  • Unwillingness or inability to give written informed consent

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Alexandre Dasilva, DDs,DMedsc, University of Michigan

Phone: 734-998-6839

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
13 November 2020
Est. completion
20 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.; 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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov