Clinical trial NCT04685343: Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
Official title: Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-12-28
Enrollment: 164
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Female aged 13-19 years
2. Self-reported menstrual cycle averaging 22-35 days
3. Regular menstrual cycles for at least 6 months
4. Access to a smartphone or email
5. Right handed
6. Body Mass Index (BMI) of 35 or less
7. Able to read and understand English
8. Ability and willingness to provide written informed assent/consent
9. Availability of a parent to provide written parental permission (for participants under age 18)

Exclusion Criteria:

1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
2. Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
3. Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
4. Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
5. Diagnosis of an eating disorder within the last 6 months
6. Current or past diagnosis of any psychotic disorder
7. Currently pregnant
8. Self-reported weekly use of alcohol, cannabis, and/or other illegal substances
9. Use of stimulants (including methamphetamine and/or medications for the treatment of ADHD) or opioids in the previous 3 months. Participants who use other analgesics will be included but will be requested to not take these analgesics within the previous 24 hours of the laboratory session
10. History of pelvic inflammatory disease or sexually transmitted disease
11. Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease). Potential participants who are being treated for cardiovascular disease(s) will be included pending discussion with the participant's primary physician
12. Developmental delay, diagnosis of autism, or significant cognitive impairment that may preclude understanding of study procedures
13. Presence of certain ferromagnetic appliance or implants (braces, retainers, spacers, wires, screws, etc.) in the mouth or any other body part that may be a contraindication for the magnetic resonance imaging (MRI) scanner
14. Significant fear of enclosed places (claustrophobia)

Primary outcomes:
measure: Menstrual pain
timeFrame: Baseline
measure: Change in menstrual pain from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in bodily pain from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Pressure pain sensitivity (PPS)
timeFrame: At baseline
measure: Pressure pain tolerance (PPT)
timeFrame: At baseline
measure: Trapezius pressure pain threshold (TPPTh)
timeFrame: At baseline
measure: Conditioned pain modulation (CPM)
timeFrame: At baseline
measure: Gray matter volume
timeFrame: At baseline
measure: White matter fiber tract values
timeFrame: At baseline
measure: Resting state networks
timeFrame: At baseline
Secondary outcomes:
measure: Change in menstrual pain from 12-months post baseline to 24-months post baseline
timeFrame: 12 months after baseline and 24 months after baseline
measure: Change in bodily pain from 12-months post baseline to 24-months post baseline
timeFrame: 12 months after baseline and 24 months after baseline
measure: Salivary pro-inflammatory cytokines
timeFrame: 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)
measure: Trapezius pressure pain threshold (TPPTh)
timeFrame: 12 months after baseline
measure: Change in conditioned pain modulation (CPM) from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in pressure pain sensitivity (PPS) from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in pressure pain tolerance (PPT) from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in gray matter volume from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in white matter fiber tract values from baseline to 12-months post baseline
timeFrame: At baseline and 12 months after baseline
measure: Change in resting state networks
timeFrame: At baseline and 12 months after baseline
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Laura Payne, PhD
role: PRINCIPAL_INVESTIGATOR
References: