← Back to Search

Sensory Testing and Brain Imaging for Menstrual Cramps

N/A

Waitlist Available

Led By Laura Payne, PhD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female aged 13-19 years

Be younger than 65 years old

Must not have

Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)

Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore the connection between brain function, pain inhibition, and chronic pain in adolescent girls.

Who is the study for?

Adolescent girls aged 13-19 with regular menstrual cycles and period pain, who are right-handed, have a BMI of 35 or less, can read English, and have access to a smartphone or email. Parental consent is required for those under 18. Exclusions include severe mental health conditions, metal implants incompatible with MRI scans, chronic pain conditions like IBS, recent use of certain medications including stimulants and hormones.

What is being tested?

The study examines the brain's response to menstrual and non-menstrual pain in teens using sensory tests and fMRI scans. It aims to identify biomarkers predicting the development of persistent or chronic pain from primary dysmenorrhea (period pain without an organic cause) over two years.

What are the potential side effects?

There are no direct side effects from participating in this trial as it involves non-invasive testing such as Quantitative Sensory Testing and fMRI scanning. However, discomfort may arise from being in enclosed spaces during MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a female between 13 and 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I experience pelvic pain all month, not just during my period.

Select...

I am currently experiencing severe depression, bipolar disorder, panic disorder, or ADHD, or am being treated for these.

Select...

I have been diagnosed with a chronic pain condition like IBS.

Select...

I have had pelvic inflammatory disease or an STD in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)

This trial's timeline: 3 weeks for screening, Varies for treatment, and three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival) for reporting.