Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
NCT04685343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2026-01-22
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
More Related Trials
-
MRI Outcomes of Mindfulness Meditation for Migraine
NCT02133209 ·Status: COMPLETED ·Phase: NA
-
Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
NCT06901232 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Brain Changes in Adolescents While Imagining and Observing Aggressive Behavior
NCT00267891 ·Status: COMPLETED
-
Fmri-based Neurofeedback With Anxious Adolescents Study
NCT02463136 ·Status: UNKNOWN ·Phase: PHASE1
-
Brain Imaging Study of Acupuncture in Chronic Low Back Pain
NCT01614639 ·Status: COMPLETED ·Phase: NA
-
Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
NCT01970943 ·Status: COMPLETED ·Phase: NA
-
Parent-Adolescent Training on Neurofeedback and Synchrony
NCT03929263 ·Status: COMPLETED ·Phase: NA
-
Treatment Of Chronic Pain Using Real Time fMRI
NCT00528346 ·Status: UNKNOWN ·Phase: PHASE2
-
Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth
NCT05472545 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Monetary Incentive Delay Task for Probing Reward-related Neural Processes
NCT06369623 ·Status: RECRUITING ·Phase: NA
-
Pediatric Neuroimaging
NCT06912724 ·Status: RECRUITING
-
Augmented Mindfulness Training for Resilience in Early Life
NCT04053582 ·Status: COMPLETED ·Phase: NA
-
Neural Injury in Adolescents With Concussion
NCT03011983 ·Status: COMPLETED
-
Brain, Brainstem, and Spinal Cord fMRI
NCT02356315 ·Status: COMPLETED
-
Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
NCT00796536 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Early Life Stress and Depression: Molecular and Functional Imaging
NCT04713722 ·Status: RECRUITING
-
Criticality, Working Memory, and Effort
NCT05797636 ·Status: COMPLETED ·Phase: NA
-
Brain Mechanisms of Attention and Pain in Youth With FAPD
NCT05892055 ·Status: WITHDRAWN
-
Cortical Excitability in Obsessive-Compulsive and Related Disorders
NCT00029068 ·Status: COMPLETED
-
Female Experiences and Brain Activity
NCT01395160 ·Status: COMPLETED
-
Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
NCT01365988 ·Status: COMPLETED
-
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
NCT05763758 ·Status: UNKNOWN
-
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
NCT01993108 ·Status: COMPLETED ·Phase: PHASE4
-
Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables
NCT07233941 ·Status: RECRUITING
-
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
NCT03606915 ·Status: COMPLETED