← Back to Search

Brain Imaging for Chronic Pain and Fatigue

N/A
Waitlist Available
Led By Roland Staud, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms.
Diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 intervals of 30 seconds each
Awards & highlights

Study Summary

This trial will use functional brain imaging to study central factors of chronic pain and fatigue, in order to better understand and treat these disorders.

Who is the study for?
This trial is for individuals with chronic pain and fatigue conditions like Fibromyalgia (FM) or Chronic Fatigue Syndrome (ME/CFS). Participants must have had symptoms persisting for over 6 months, meet specific criteria for tender points in FM, or certain symptom counts in ME/CFS. They should be willing to lower their antidepressant doses substantially.Check my eligibility
What is being tested?
The study uses functional magnetic resonance imaging (fMRI) to investigate brain and spinal cord abnormalities that may contribute to chronic pain and fatigue. It aims to understand the central mechanisms behind these conditions by observing how the nervous system functions during sensory testing.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging techniques like fMRI and sensory testing devices rather than drugs, side effects are minimal but can include discomfort from lying still during scans or temporary sensations from sensory tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had chronic fatigue for over 6 months and at least four related symptoms.
Select...
I have had chronic fatigue for over 6 months and at least four specific symptoms.
Select...
I have been diagnosed with fibromyalgia and have widespread pain and tenderness in many areas.
Select...
I am willing to lower my antidepressant doses for the trial.
Select...
I have been diagnosed with fibromyalgia and have widespread pain and at least 11 tender points.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 intervals of 30 seconds each
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 intervals of 30 seconds each for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in experimental Pain from mechanical stimulation to the upper extremities and the shoulder
Change in experimental pain from heat pulses to the upper extremities
Secondary outcome measures
Change in Fatigue Ratings

Trial Design

3Treatment groups
Experimental Treatment
Group I: Healthy ControlExperimental Treatment3 Interventions
normal volunteers (HC) Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments.
Group II: Fibromyalgia OnlyExperimental Treatment3 Interventions
The diagnosis of FM will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments.
Group III: Chronic fatigue and Fibromyalgia SyndromeExperimental Treatment3 Interventions
Diagnosis of ME/CFS will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms. Undergoing sensory testing, brain and spinal cord neuroimaging and Inventory assessments.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,447 Total Patients Enrolled
7 Trials studying Fibromyalgia
639 Patients Enrolled for Fibromyalgia
Roland Staud, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
246 Total Patients Enrolled
4 Trials studying Fibromyalgia
246 Patients Enrolled for Fibromyalgia

Media Library

functional magnetic resonance imaging for Brain Neuroimaging Clinical Trial Eligibility Overview. Trial Name: NCT03075254 — N/A
Fibromyalgia Research Study Groups: Fibromyalgia Only, Chronic fatigue and Fibromyalgia Syndrome, Healthy Control
Fibromyalgia Clinical Trial 2023: functional magnetic resonance imaging for Brain Neuroimaging Highlights & Side Effects. Trial Name: NCT03075254 — N/A
functional magnetic resonance imaging for Brain Neuroimaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03075254 — N/A

Frequently Asked Questions

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

What are the eligibility requirements for participation in this clinical trial?

"Eligibility requirements for this clinical study include an 18 to 70 year old who has been diagnosed with fibromyalgia. Currently, they are looking to enrol a total of 197 participants."

Answered by AI

Is this trial recruiting participants of an older age demographic?

"This particular medical study is open to individuals aged 18 and above, but below the age of 70."

Answered by AI

Are there any active recruitment efforts for this trial currently underway?

"According to the information sourced from clinicaltrials.gov, this medical trial is no longer taking new candidates. The study was first launched in March of 2017 and its last update occurred on June 7th 2022. However, 697 other trials are still actively seeking patients."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Oregon
California
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Florida
How many prior treatments have patients received?
1
~17 spots leftby Dec 2024