Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02332694
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18-65.
* Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
* A diagnosis Fibromyalgia based on a clinician's diagnosis.
* In the investigator's opinion, has met criteria for Fibromyalgia for at least 4 weeks prior to signing consent.
* Able to communicate in English with study personnel.
* For women, must not be pregnant (per urine test)
Exclusion Criteria:
* Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
* A current DSM-IV-TR Axis I diagnosis of Dementia; or
* Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
* A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
* A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
* A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
* Subject has met DSM-IV criteria for Substance Abuse in the month prior to screening visit
* A diagnosis of an anxiety or mood disorder that is considered by the investigator to be of greater source of distress or functional impairment than the patient's FIBROMYALGIA diagnosis. Subjects with comorbid anxiety and mood disorders not excluded above and considered to be of secondary importance will be permitted in the study.
* Participation in concurrent formal psychotherapy during the trial, or in the 2 weeks prior to the screening visit.
* Subject has a medical condition or disorder that:
* Is unstable and clinically significant, or:
* Could interfere with the accurate assessment of safety or efficacy of treatment, including:
* individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,
* individuals with cardiovascular conditions or problems (uncontrolled hypertension, congestive heart failure, or documented evidence of coronary artery disease)
* individuals with chronic conditions/diseases associated with a reduced ability initiate thermoregulatory cooling, including Parkinson's, multiple sclerosis, central nervous system tumors, and diabetes with neuropathy,
* hemophiliacs/individuals prone to bleeding,
* individuals with a fever the day of study intervention (if so, they will be rescheduled),
* individuals with hypersensitivity to heat,
* individuals with recent acute joint injury (i.e. arthritis),
* individuals with enclosed infections, be they dental, in joints, or in any other tissues,
* Clinically significant, in the investigator's opinion, abnormal findings on screening laboratory tests or physical exam.
* Use of any psychotropic medications for 2 weeks (8 weeks for fluoxetine) prior to initiation of the study, with the exception of a stable dosage of benzodiazepine or non-benzodiazepine hypnotic medications (e.g. zolpidem (Ambien), zaleplon (Sonata), eszopiclone (Lunesta), lorazepam (Ativan), diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax),
* Need for any non-protocol psychotropic medication once enrolled, with the exception of benzodiazepine or non-benzodiazepine hypnotics used at a stable dosage.
* Women who are pregnant (HCG pregnancy test at screening, or lactating, or who plan to become pregnant during the study.
* Current participation in any clinical trial that might impact results of this one, which includes participation in another clinical trial, as well as drug trials with agents that might affect mood or regulation of body temperature or core fibromyalgia symptoms
* Reasonable likelihood for non-compliance with the protocol for any other reason, in the opinion of the Investigator, prohibits enrollment of subject into the study.
* Obesity and overall size of subject. It will be up to the PI's discretion to consider BMI, waist circumference, and body fat composition when determining eligibility and safety of the individual.
* History of peripheral circulatory disease, for example peripheral vascular disease, deep vein thrombosis (DVT), or lymphedema.
* History of a cerebral vascular accident
* History of stroke, epilepsy or cerebral aneurisms
* Cancer in the last five years, except for fully resected non-melanoma skin cancer.
* Diabetes mellitus types I or II.
* Any clinically significant autoimmune disease (compensated hypothyroidism allowed)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02332694
Study Brief:
Protocol Section:
NCT02332694