Fibromyalgia 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:

• People who are willing and able to give their formal agreement to take part in the study.
• People who are 22 years of age or older.
• People who have been diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria, which includes widespread pain across at least 4 of 5 body regions, specific pain and symptom scores meeting set thresholds, and symptoms present at a similar level for at least 3 months.
• People for whom at least two standard fibromyalgia medications (such as pregabalin, duloxetine, or milnacipran) have not worked well enough.
• People who have tried at least one physical or talking-based therapy for fibromyalgia without adequate relief — this includes a wide range of options such as aerobic exercise, hydrotherapy, yoga, massage, Tai Chi, Pilates, physiotherapy techniques, heat or cold therapy, mindfulness, mirror therapy, graded motor imagery, or cognitive behavioural therapy (CBT), among others.
• People whose pain score is 4 or higher on an 11-point pain scale (where 0 is no pain and 10 is the worst pain) at the initial screening visit.
• People whose pain score averages 4 or higher on that same scale across 3 days in a row before the study begins.
• People who are willing and able to follow all study procedures throughout the trial.
• People who have been on the same mental health treatment (such as medication or therapy) for at least one month before screening and are willing to stay on that same treatment for the duration of the study, unless a change is recommended by the trial doctor.
• People who could potentially become pregnant must have a negative pregnancy test at screening and must agree to use a highly effective form of contraception during the study (such as an IUD, tubal ligation, vasectomized partner, or long-acting contraceptive with a less than 1% chance of pregnancy).

Who may not be able to join:

• People who have ever been diagnosed with bipolar disorder or a schizophrenia-related condition at any point in their life.
• People who have had a moderate or severe alcohol or drug use disorder in the past 6 months.
• People who have had an unstable diagnosis of obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD) in the past 30 days, as determined by the trial doctor.
• People who have had a primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months.
• People with a clinically significant neurodevelopmental, cognitive, or personality disorder, as assessed by the trial doctor.
• People assessed as being at moderate or high risk of suicide, based on a standard screening tool or the trial doctor's judgement.
• People who have a lifetime history of a serious suicide attempt, in the medical opinion of the trial doctor.
• People whose pain treatment has changed in the past 2 months.
• People who have received electroconvulsive therapy, transcranial magnetic stimulation, ketamine, or esketamine in the past 30 days.
• People with a progressive neurological disease such as multiple sclerosis, a brain or spinal cord tumour, or severe spinal stenosis.
• People whose pain is caused by cancer.
• People diagnosed with a cancer (other than certain minor skin cancers) within the past five years, or with a life expectancy of less than one year due to advanced cancer.
• People whose pain is caused by an autoimmune condition.
• People with a general medical condition that is not adequately managed, in the opinion of the trial doctor.
• People with a lifetime history of small vessel disease in the brain.
• People with a lifetime history of bleeding inside the skull (intracranial haemorrhage).
• People who are currently pregnant or breastfeeding.
• People who have a medical device implanted in their head or neck.
• People who are unable to have an MRI scan or who cannot tolerate the procedure.
• People who have previously taken part in a DIADEM clinical trial (note: people who were screened but did not proceed may be rescreened once).
• People with any other medical or psychiatric history, condition, or circumstance that the trial doctor believes could affect their ability to participate safely or could affect the reliability of the study results.
• People with braids, dreadlocks, or other hairstyles that block access to the side of the head, who are unwilling to temporarily adjust their hairstyle for the procedure.

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