Functional Abdominal Pain SyndromeNCT05892055
Brain Mechanisms of Attention and Pain in Youth With FAPD
An observational study of Functional Abdominal Pain Syndrome, run by Michigan State University at 1 site in United States.
Trial summary
The objectives of this study are to identify neural mechanisms of increased pain in pediatric FAPD and examine mechanisms of disrupted attention in the presence of induced pain. The overarching goal is to determine whether youth with FAPD process pain differently than healthy youth and to identify the brain areas… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- MRI Procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 28 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 10 youth with be recruited to pilot test the procedures outside of the scanner (up to 5 HC and up to 5 with FAPD). Then, for the active part of the study, a total of 50 participants will be recruited (25 with FAPD and 25 HC). Children with FAPD will be recruited based on the presence of an FAPD diagnosis (see inclusion/exclusion criteria). Healthy controls (HC) will not have an FAPD diagnosis.
Who may be able to join
- Children (boys and girls) between 11-16 years of age and their parent/primary caregiver.
- Meets criteria for one of two study groups:
- FAPD: based on physician diagnosis of FAPD confirmed by a validated Rome IV measure.
- HC: based on a rule out of an FAPD diagnosis (using the Rome IV measure).
- We will recruit approximately 50% of HCs with and without clinical levels of anxiety (e.g,. SCARED cut-off score greater than or equal to 25) to match the anxiety levels anticipated in the FAPD group.
- Sufficient English language ability necessary to complete study measures and protocol
Who cannot join
- Children with significant medical condition(s) with an identifiable organic cause including those that may account for abdominal pain symptoms (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Crohn's Disease). Rationale: Children with a significant medical condition may impact the study results. Further, youth with organic conditions that include abdominal pain may not meet criteria for FAPD even if they present with similar symptoms.
- Children with a documented developmental delay, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder will be excluded. Rationale: These comorbidities may confound the study aims by impacting the dependent measures.
- Significant visual, hearing, or speech impairment. Rationale: Children will be excluded if they are not able to see the testing stimuli, hear the test examiner, or respond verbally to the test examiner, even with the help of corrective or assistive devices (e.g., glasses, hearing aids).
- Organic brain injury. Rationale: Children must not have a history of epilepsy, a head trauma associated with a loss of consciousness, or any other organic disorder since these conditions could possibly affect brain function and cognition and interfere with study results.
- *Other exclusionary criteria specific to the fMRI component of the study:
- Participants with an implant such as a cochlear implant device, a pacemaker or neurostimulator containing electrical circuitry or generating magnetic signals will be excluded. Participants must also not have any significant ferrous material in their body that could pose the potential for harm in the fMRI environment or cause signal suppression of key regions (i.e. orthodontia). Rationale: Implant devices can malfunction and/or be damaged. Strong magnetic fields in the fMRI environment can cause some metallic objects to move and/or heat, and therefore pose a safety risk. All children will be screened prior to participation using a standardized questionnaire in the fMRI component of the study to ensure that the fMRI magnetic fields will not pose any risk to their safety.
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- Female participants who report current/suspected pregnancy will be excluded. Rationale: There is minimal yet potential fetal risk due to electromagnetic radiation from the MRI. Female participants who self-report that they may be pregnant will be excluded from the study.
- Participants with evidence of claustrophobia will be excluded. Rationale: Such participants may experience extreme distress when entering the fMRI scanner. Claustrophobia will be assessed using a validated module of the Anxiety Disorders Interview Schedule as part of the initial screening process. Youth will be excluded from participating if they report excessive fear of enclosures.
- Note that these exclusionary criteria do not apply to those recruited for the study's pilot portion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Brain Mechanisms of Attention and Pain in Youth With Functional Abdominal Pain Disorders
The objectives of this study are to identify neural mechanisms of increased pain in pediatric FAPD and examine mechanisms of disrupted attention in the presence of induced pain. The overarching goal is to determine whether youth with FAPD process pain differently than healthy youth and to identify the brain areas involved.
Read the detailed description
The goal of the current project is to enhance understanding of the neural mechanisms associated with the pain experience in youth with functional abdominal pain disorders (FAPD), which is the most common and debilitating presentation of FAPD. This study will examine the neural mechanisms associated with pain induction and diminished attentional regulation during pain in FAPD. Findings from pilot studies indicate that increased anxiety in FAPD is associated with higher pain-related impairment, and that anxiety may adversely impact response to a cognitive behavioral intervention for pain. While pain outcomes improve when anxiety is also addressed in treatment for FAPD, a sizable portion fail to respond to currently available interventions. Further, the PI found that induced pain in FAPD is associated with changes in regional brain activity and functional connectivity between brain regions that are implicated in chronic pain. It is crucial to better understand the neural mechanisms which may place youth with FAPD at risk for poorer outcomes in order to ultimately develop more effective treatments. In this study, neural mechanisms of response to a pain symptom provocation task in youth with FAPD will be compared to healthy controls. The impact of anxiety levels will also be explored. This study will also examine neural mechanisms associated with disrupted attentional regulation during pain induction in youth with FAPD.
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- MRI Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ProcedureOther
All children will receive a functional magnetic resonance imaging (fMRI) scan, where they will complete some preliminary scans while completing two cognitive tasks, and then be removed from the scanner to complete a water loading symptom provocation task (WL-SPT). After the WL-SPT task, they will resume the fMRI scan and complete additional cognitive tasks to assess for diminished attentional regulation. Measures of pain intensity, pain unpleasantness, and state anxiety will be obtained throughout.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control (HC) | Healthy controls (HC) will not have an FAPD diagnosis. The HC group receives the same procedures as the FAPD group. Receives: Other: MRI Procedure | |
| FAPD | Children in the FAPD group will be recruited based on the presence of an FAPD diagnosis and receive the same procedures as the HC group. Receives: Other: MRI Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Mechanisms During Pain Induction
Amygdala-Prefrontal Cortex (AMY-PFC) functional connectivity will be enhanced following WL-SPT in the FAPD group vs HC. Increased brain activity and functional connectivity will correspond to higher pain in FAPD.
Measured: Approximately 1.5 hours
Secondary outcomes (1)
Attentional Regulation During Cognitive Task
Functional connectivity between the AMY-PFC will be enhanced during a cognitive task, which will be related to higher pain ratings and response time.
Measured: Approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start28 Feb 2019
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Why it stopped: No participants were enrolled for the active phase of this study (with neuroimaging), but, n=6 (n=3 with FAPD and n=3 Healthy) completed the pilot testing protocol outside of the scanner between 2/28/2019 and 3/28/2019. No neuroimaging took place.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health West
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892055
- Sponsor's protocol ID
- 2018-4315
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2019
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Attention and Pain in Youth With Functional Abdominal Pain Disorders
- ClinicalTrials.gov ID
- NCT05892055
- Acronym / sponsor ID
- 2018-4315
- Conditions
- Functional Abdominal Pain Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled for the active phase of this study (with neuroimaging), but, n=6 (n=3 with FAPD and n=3 Healthy) completed the pilot testing protocol outside of the scanner between 2/28/2019 and 3/28/2019. No neuroimaging took place.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Corewell Health West
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to identify neural mechanisms of increased pain in pediatric FAPD and examine mechanisms of disrupted attention in the presence of induced pain. The overarching goal is to determine whether youth with FAPD process pain differently than healthy youth and to identify the brain areas involved.
Detailed description
The goal of the current project is to enhance understanding of the neural mechanisms associated with the pain experience in youth with functional abdominal pain disorders (FAPD), which is the most common and debilitating presentation of FAPD. This study will examine the neural mechanisms associated with pain induction and diminished attentional regulation during pain in FAPD. Findings from pilot studies indicate that increased anxiety in FAPD is associated with higher pain-related impairment, and that anxiety may adversely impact response to a cognitive behavioral intervention for pain. While pain outcomes improve when anxiety is also addressed in treatment for FAPD, a sizable portion fail to respond to currently available interventions. Further, the PI found that induced pain in FAPD is associated with changes in regional brain activity and functional connectivity between brain regions that are implicated in chronic pain. It is crucial to better understand the neural mechanisms which may place youth with FAPD at risk for poorer outcomes in order to ultimately develop more effective treatments. In this study, neural mechanisms of response to a pain symptom provocation task in youth with FAPD will be compared to healthy controls. The impact of anxiety levels will also be explored. This study will also examine neural mechanisms associated with disrupted attentional regulation during pain induction in youth with FAPD.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control (HC) | – | Other: MRI ProcedureHealthy controls (HC) will not have an FAPD diagnosis. The HC group receives the same procedures as the FAPD group. |
| FAPD | – | Other: MRI ProcedureChildren in the FAPD group will be recruited based on the presence of an FAPD diagnosis and receive the same procedures as the HC group. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 10 youth with be recruited to pilot test the procedures outside of the scanner (up to 5 HC and up to 5 with FAPD). Then, for the active part of the study, a total of 50 participants will be recruited (25 with FAPD and 25 HC). Children with FAPD will be recruited based on the presence of an FAPD diagnosis (see inclusion/exclusion criteria). Healthy controls (HC) will not have an FAPD diagnosis.
Key inclusion criteria (6 listed)
- Children (boys and girls) between 11-16 years of age and their parent/primary caregiver.
- Meets criteria for one of two study groups:
- We will recruit approximately 50% of HCs with and without clinical levels of anxiety (e.g,. SCARED cut-off score greater than or equal to 25) to match the anxiety levels anticipated in the FAPD group.
- Sufficient English language ability necessary to complete study measures and protocol
Key exclusion criteria (9 listed)
- Children with significant medical condition(s) with an identifiable organic cause including those that may account for abdominal pain symptoms (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Crohn's Disease). Rationale: Children with a significant medical condition may impact the study results. Further, youth with organic conditions that include abdominal pain may not meet criteria for FAPD even if they present with similar symptoms.
- Children with a documented developmental delay, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder will be excluded. Rationale: These comorbidities may confound the study aims by impacting the dependent measures.
- Significant visual, hearing, or speech impairment. Rationale: Children will be excluded if they are not able to see the testing stimuli, hear the test examiner, or respond verbally to the test examiner, even with the help of corrective or assistive devices (e.g., glasses, hearing aids).
- Organic brain injury. Rationale: Children must not have a history of epilepsy, a head trauma associated with a loss of consciousness, or any other organic disorder since these conditions could possibly affect brain function and cognition and interfere with study results.
- *Other exclusionary criteria specific to the fMRI component of the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ProcedureAll children will receive a functional magnetic resonance imaging (fMRI) scan, where they will complete some preliminary scans while completing two cognitive tasks, and then be removed from the scanner to complete a water loading symptom provocation task (WL-SPT). After the WL-SPT task, they will resume the fMRI scan and complete additional cognitive tasks to assess for diminished attentional regulation. Measures of pain intensity, pain unpleasantness, and state anxiety will be obtained throughout. | Other | FAPD, Healthy Control (HC) |
Primary outcome
Neural Mechanisms During Pain Induction
Time frame: Approximately 1.5 hours
Amygdala-Prefrontal Cortex (AMY-PFC) functional connectivity will be enhanced following WL-SPT in the FAPD group vs HC. Increased brain activity and functional connectivity will correspond to higher pain in FAPD.
1 secondary outcome
Attentional Regulation During Cognitive Task
Time frame: Approximately 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Abdominal Pain Syndrome, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Mechanisms During Pain Induction (time frame: Approximately 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.