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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

No Placebo-Only Group

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:

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I am willing and able to adjust my pain, sleep, anxiety, or depression medications for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 intervals of 30 seconds each

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met