Early Phase 1 Chronic Fatigue Syndrome Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For healthy volunteers:

• People aged 18 to 50 who are in good general health, based on their medical history and/or a physical check-up
• People who are willing and able to understand and sign a consent form, and are available to take part for the full duration of the study

For people with ME/CFS:

• People aged 18 to 50 who have a formal diagnosis of ME/CFS that meets at least one of three recognised sets of diagnostic standards: the 1994 Fukuda Criteria, the 2003 Canadian Consensus Criteria, or the Institute of Medicine Diagnostic Criteria
• People who are willing and able to understand and sign a consent form, and are available to take part for the full duration of the study

Who may not be able to join:

For healthy volunteers:

• People who currently have a major neurological or psychiatric condition, such as stroke, Parkinson's disease, Alzheimer's disease, schizophrenia, or major depression
• People who currently have another significant medical condition, such as kidney disease, liver disease, heart disease, or a chronic pain condition, that in the lead researcher's view could make participation unsafe or difficult
• People who are currently taking medications that primarily affect the brain and nervous system, such as antidepressants or stimulants
• People who have used opioid pain medications for more than two weeks at any point in the last two years, or at all in the last month
• People with a current or past history of a substance use disorder, binge drinking, illegal drug use, or heavy tobacco use (more than 10 cigarettes per week)
• People who use cannabis more than occasionally, defined as use on more than one or two days in the last two weeks (confirm with trial site)
• People who use any other illicit drugs or misuse prescription medications (confirm with trial site)
• People with a condition or injury that affects their grip
• People with a condition or injury affecting their arms or legs that would change their skin's sensitivity to heat or cold pain testing, or make such testing unsafe
• People for whom an MRI scan would be unsafe — for example, those with metal in the skull or eye, an implanted nerve stimulator, cochlear implant, cardiac pacemaker, defibrillator, or implanted pump; those with non-removable body piercings; those with claustrophobia; those unable to lie still for 90 minutes; or those who are pregnant or planning to become pregnant during the study
• Staff members of the NINDS Brain Network Unit (BNU) and their immediate family members
• People who do not speak English, as some of the study tools have not been validated in other languages

For people with ME/CFS:

• People who have a major neurological or psychiatric condition in addition to their ME/CFS, such as stroke, Parkinson's disease, Alzheimer's disease, schizophrenia, or major depression
• People who have another significant medical condition in addition to their ME/CFS, such as kidney disease, liver disease, heart disease, or a chronic pain condition, that in the lead researcher's view could make participation unsafe or difficult
• People who are currently taking psychomotor stimulants, antipsychotics, or benzodiazepines
• People who have used opioid pain medications for more than two weeks at any point in the last two years, or at all in the last month
• People with a current or past history of a substance use disorder, binge drinking, illegal drug use, or heavy tobacco use (more than 10 cigarettes per week)
• People who use cannabis more than occasionally, defined as use on more than one or two days in the last two weeks (confirm with trial site)
• People who use any other illicit drugs or misuse prescription medications (confirm with trial site)
• People with a condition or injury that affects their grip
• People with a condition or injury affecting their arms or legs that would change their skin's sensitivity to heat or cold pain testing, or make such testing unsafe
• People for whom an MRI scan would be unsafe — for example, those with metal in the skull or eye, an implanted nerve stimulator, cochlear implant, cardiac pacemaker, defibrillator, or implanted pump; those with non-removable body piercings; those with claustrophobia; those unable to lie still for 90 minutes; or those who are pregnant or planning to become pregnant during the study
• Staff members of the NINDS Brain Network Unit (BNU) and their immediate family members
• People who do not speak English, as some of the study tools have not been validated in other languages

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