Functional Abdominal Pain Syndrome Clinical Trial
Official title:
Brain Mechanisms of Attention and Pain in Youth With Functional Abdominal Pain Disorders
NCT number | NCT05892055 |
Other study ID # | 2018-4315 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | February 28, 2019 |
Est. completion date | March 28, 2019 |
Verified date | May 2023 |
Source | Michigan State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 28, 2019 |
Est. primary completion date | March 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Children (boys and girls) between 11-16 years of age and their parent/primary caregiver. 2. 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. 3. Sufficient English language ability necessary to complete study measures and protocol Exclusion Criteria 1. 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. 2. 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. 3. 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). 4. 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. 5. *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. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Michigan State University | Spectrum Health Hospitals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Approximately 1.5 hours | |
Secondary | 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. | Approximately 30 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
Completed |
NCT02565355 -
Targeted Food Elimination for Treatment of Functional Gastrointestinal Diseases in Children
|
N/A | |
Recruiting |
NCT05491499 -
Assessing the Impact of Exercise Based Intensive Interdisciplinary Pain Treatment (IIPT) on Endogenous Pain Modulation in Youth With Chronic Pain Syndromes
|
||
Recruiting |
NCT05486585 -
i-CBT Functional Gastrointestinal Disorders in Youth: the Impact of Negative Illness Understanding and Parental Illness Worries
|
N/A | |
Recruiting |
NCT05945251 -
ICBT for Children With FAPDs - the Child's Pain Regulation
|
||
Recruiting |
NCT05799053 -
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
|
Phase 3 | |
Recruiting |
NCT05814497 -
Supraspinal Processing of Sensory Aspects of Pain
|
N/A | |
Active, not recruiting |
NCT05636358 -
Hypnotherapy Through Self-exercises in Children With Functional Abdominal Pain in Primary Care
|
N/A | |
Completed |
NCT02030392 -
A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
|
N/A | |
Recruiting |
NCT06310733 -
The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders
|
Phase 4 | |
Recruiting |
NCT02613078 -
Hypnotherapy vs. Probiotics in Children With IBS and Functional Abdominal Pain
|
N/A | |
Completed |
NCT03078634 -
The Multi-disciplinary Treatment of Functional Gut Disorders Study
|
N/A | |
Recruiting |
NCT06268964 -
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04619095 -
Reducing Pain and Anxiety Through Dietary Fiber Supplementation in Children With Abdominal Pain
|
N/A | |
Completed |
NCT03771027 -
Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
|
N/A | |
Completed |
NCT03518216 -
Neural Mechanisms of Treatment Response to ADAPT
|
N/A | |
Completed |
NCT03134950 -
Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
|
N/A | |
Completed |
NCT03931330 -
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
|
N/A | |
Recruiting |
NCT03823742 -
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
|
N/A | |
Not yet recruiting |
NCT04320550 -
Frequency of Functional Gastrointestinal Disorders in Children
|