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NCT04685343 · ClinicalTrials.gov registry record · NA
Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
A NA study, sponsored by Mclean Hospital.
- Completed
- Registry status
- NA
- Development phase
- 164
- Enrollment target
NCT04685343 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 164 participants.
The verdict
NCT04685343, a NA study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
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.
Interventions
- OTHER fMRI
- BEHAVIORAL Quantitative Sensory Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2025-12-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04685343
The ClinicalTrials.gov registry entry for NCT04685343 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which fMRI is the first listed.
NCT04685343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04685343 about?
NCT04685343 is a clinical study titled "Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents". 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...
What is the current status of trial NCT04685343?
This trial is currently completed. It is a NA study. The enrollment target is 164 participants. The study started on 2020-12-14. Estimated completion is 2025-12-24.
What interventions are being tested in trial NCT04685343?
The interventions under investigation include: fMRI (OTHER), Quantitative Sensory Testing (BEHAVIORAL).
Who is sponsoring clinical trial NCT04685343?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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