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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.
Must not have
Patients unwilling or unable to discontinue or modify analgesics, hypnotics, anxiolytics, or anti-depressants during the study period will be excluded from this trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 intervals of 30 seconds each
Awards & highlights

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.
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.
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
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I have had chronic fatigue for over 6 months and at least four related symptoms.
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I have had chronic fatigue for over 6 months and at least four specific symptoms.
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I have been diagnosed with fibromyalgia and have widespread pain and tenderness in many areas.
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I have been diagnosed with fibromyalgia and have widespread pain and at least 11 tender points.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing and able to adjust my pain, sleep, anxiety, or depression medications for the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
1,380 Previous Clinical Trials
762,198 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
~4 spots leftby Dec 2024
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