Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

NCT04685343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-01-22

No results posted yet for this study

Summary

The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent girls, ages 13-19. Participants will undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices brain structure and function at baseline and 12 months later. Menstrual pain severity and non-menstrual bodily pain will be assessed monthly for 24 months. Aims of the study are: 1) to identify the central mechanisms of PD using measures of pain inhibition and brain structure and connectivity of sensorimotor, default, emotional arousal, and salience networks, 2) to determine deficits in pain inhibition and alterations in brain structure and network connectivity that predict the one-year developmental trajectories of menstrual pain and non-menstrual bodily pain, and 3) to identify the dynamic relationship between alterations in pain inhibition and brain structure and connectivity with symptom change in menstrual pain and non-menstrual bodily pain. We hypothesize that deficits in endogenous pain inhibition and alterations in brain structure, connectivity, and function of regional networks will be positively associated with menstrual pain severity ratings at baseline and predict the trajectory of menstrual and non-menstrual bodily pain over 2 years. The results are expected to identify specific mechanisms and characteristics that predict the transition from acute/cyclical pain to persistent or chronic pain, which will support the development of therapies to prevent the transition from recurrent to chronic pain in adulthood.

Conditions

  • Primary Dysmenorrhea

Interventions

BEHAVIORAL

Quantitative Sensory Testing

Quantitative sensory testing (QST) consisting of 4 pain induction and sensory sensitivity tasks (i.e., pressure applied to the thumbnail, arms, shoulders, and lower abdomen, a cold water task, and one video-watching task).

OTHER

fMRI

Functional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Laura Payne, PhD · Mclean Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2025-12-24
Completion
2025-12-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685343 on ClinicalTrials.gov