Endometriosis and Migraine

Conditions

• Endometriosis
• Migraine

Eligibility Criteria

Sex

FEMALE

Age

12 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Thermal stimuli — DEVICE
  The Thermal Sensory Analyzer (TSA-II or PATHWAY platform - Medoc, Ramat Yishai, Israel) will be used to safely deliver heat and cold stimuli. These devices can deliver relatively complex stimuli via computer control. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water container or a water bath (FISHER, USA). Participants will be free to pull out of the water bath at any time
• Pressure stimuli — DEVICE
  Pressure stimuli will be applied by using a handheld algometer (Wagner Instruments) or the Pressure Algometer (Medoc, Ramat Yishai, Israel). These devices have a round probe that allows quantifying the amount of pressure that is being applied. The Pressure Algometer allows a real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.
• Pain ratings — BEHAVIORAL
  Pain intensity and pain unpleasantness ratings will be assessed.
• Conditioned pain modulation (CPM) response — BEHAVIORAL
  The CPM paradigm assesses endogenous inhibitory pain modulation efficiency. CPM testing includes the application of a "test" stimulus without conditioning (control run, pressure pain thresholds) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run, a 60 second of foot immersion in cold water). The CPM response is the difference in the pressure pain thresholds between the control and the conditioning runs.
• Hormonal assessment — BIOLOGICAL
  Blood samples (approximately 2 tablespoons) and/or saliva and/or urine will be collected for analyses of sex hormone levels (e.g., prolactin, testosterone, estradiol).

Study Details

This study aims to determine differences in experimental pain and sex hormone levels between patients with migraine, patients with endometriosis, patients with migraine and endometriosis, and healthy controls. Participants will complete surveys, experimental pain paradigms and collection of samples for hormone analyses.

Key Dates

Start date

Feb 12, 2025

Status verified

Aug 2025

Primary completion

Jan 1, 2028

Completion

Jan 1, 2030

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: migraine
  patients with migraine
• Arm: Endometriosis
  patients with endometriosis
• Arm: migraine and endometriosis
  patients with migraine and endometriosis
• Arm: control
  healthy participants with no migraine or endometriosis

Primary Outcome Measure

Conditioned pain modulation (CPM) response [ Time Frame: Baseline ]

Central Contacts

• Alana McMichael, MA
  314-273-6194
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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