Phase
Condition
Pain
Treatment
N/AClinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent provided by the participant
Ages 18-50 years
English speaking
GM persons who have been deemed to be an appropriate medical candidate to takegender-affirming hormone therapy for gender incongruence -OR- GM persons who are nottaking gender-affirming hormone therapy
Aim 2 (QST and MRI) Additional Inclusion Criteria:
GM persons who have been deemed to be an appropriate medical candidate to takegender- affirming hormone therapy for gender incongruence
Stable doses of analgesic medications for at least 30 days prior to screening
Right handed
Normal visual acuity or correctable to at least 20/40 for reading instructions inthe MRI
Willingness to refrain from pain medications such as NSAIDs, acetaminophen, andopioid medications for 12 hours prior to neuroimaging and QST
Willingness to refrain from alcohol and nicotine on day of QST and neuroimaging
Willingness to refrain from physical activity or exercise that would cause muscleand/or joint soreness for 48 hours prior to testing (routine exercise or activitythat does not lead to soreness is acceptable)
Investigators will attempt to recruit individuals with no chronic daily use ofadjunctive pain medications, including tricyclic antidepressants,serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs caninfluence neuroimaging and QST findings, or have individuals be weaned off of thesemeds at least two weeks prior to being studied. In previous smaller imaging studiesinvestigators could accomplish this, but this may not be possible in this large of astudy. If the study team does need to allow individuals into these cohorts while onsuch medications because of pragmatic issues, this information will be recorded andpatients will be asked to remain on a stable dose for at least two weeks prior toMRI and QST assessments.
Able to lie still on their back for 1.5 hours for MRI scans
Exclusion
Exclusion Criteria:
Inability to provide informed consent
Age less than 18 years or greater than 50 years
Severe physical impairment (e.g., blindness, deafness, paraplegia)
Co-morbid medical conditions that may significantly impair physical functionalstatus (e.g., history of non-skin malignancy, or autoimmune disorder)
Pregnant or nursing
Liver failure
Self-reported liver cirrhosis
Self-reported hepatitis
Severe Cardiovascular disease (examples: history of myocardial infarction, unstableangina, severe coronary artery disease, congestive heart failure, or severe valvularabnormalities) that are self-reported by patient or by medical record
Prisoner
Current litigation for chronic pain
Current disability proceedings
Active psychotic or suicidal symptoms
Current drug or alcohol use disorder
History of gonadectomy surgery
Aim 2 (QST and MRI) Additional Inclusion Criteria:
Contraindications to MRI (e.g., metal implants, pacemaker, etc.)
Severe claustrophobia precluding MRI and evoked pain testing during scanning
BMI > 40 or unable to lie comfortably in MRI
Current, recent (within the last 6 months), or habitual use of artificial nails ornail enhancements. (Artificial nails can influence pressure pain sensitivity at thethumbnail)
Peripheral neuropathy
Diagnosed epilepsy or seizure history
Study Design
Study Description
Connect with a study center
The University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting

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