NCT07052344 Gut-Brain Neural Coupling in Spinal Cord Injury
| NCT ID | NCT07052344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-10-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI).
Eligibility Criteria
Inclusion Criteria, SCI and Controls * Adults, 18 to 70 years of age. * Sex, male or female. * Weight-stable (±3 kg) for the preceding 3 months (self-report). * Physically inactive adults not meeting weekly activity guidelines (\<150 min/week) for the preceding 3 months (self-report). * Fluent in written and spoken English. Exclusion Criteria, SCI and Controls * Do not meet the inclusion criteria. * Current/regular smoker (defined by Center for Disease Control (CDC)/ National Institute of Health (NIH) as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes either every day or every other day) (self-report). * Currently dieting and/or trying to gain or lose weight. * Vagus or recurrent laryngeal nerve injury (self-report). * Uncontrolled thyroid disease, such that they are not on thyroid medication (e.g., levothyroxine) to treat the condition (self-report) * Diabetes (type 1 or type 2) and/or currently taking anti-diabetic or glucagon-like peptide-1 (GLP-1)/dual agonist medications (self-report). * Gastrointestinal disease (self-report), such as inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, irritable bowel syndrome, gastroesophageal reflux disease, peptic ulcer disease, chronic pancreatitis, liver cirrhosis, and any condition requiring gastrointestinal surgery (e.g., bowel resection, colostomy, or ileostomy). * Swallowing disorder (self-report). * History of bariatric surgery * Food allergies/dislikes or dietary restrictions (i.e. vegan) (self-report). * Allergy to adhesives (self-report) * Open abdominal wounds or abdominal skin not intact. * Current use of probiotics/prebiotics (self-report). * Current use of medications that can impact appetite, body weight, and/or bowel function, such as prokinetic, antiemetic, narcotic analgesics, anticholinergic, anti-inflammatory, antipsychotic, or anti-obesity agents (self-report). * Pregnant (determined by urine pregnancy test) or breastfeeding women. * Non-adults (infants, children, teenagers). * Adults unable to consent * Prisoner. SCI-specific Eligibility Criteria Inclusion Criteria, SCI Only * At least 12 months post-SCI, denoting chronic injury * Complete American Spinal Injury Association (ASIA) Impairment Scale (AIS A) or motor-incomplete (AIS B) tetraplegia (SCI at or above C8 lesion) * Able to self-feed (self-report) * On a bowel care program every day or every other day (self-report). Exclusion Criteria, SCI Only * Under 12 months post-SCI. * Motor-incomplete (AIS C, D) paraplegia (SCI below C8 lesion), including thoracic, lumbar, and sacral injuries. * Ventilator-dependence (self-report).
Contact & Investigator
Gary J Farkas, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07052344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07052344 currently recruiting?
Yes, NCT07052344 is actively recruiting participants. Contact the research team at gxm1228@med.miami.edu for enrollment information.
Where is the NCT07052344 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07052344 clinical trial?
NCT07052344 is sponsored by University of Miami. The principal investigator is Gary J Farkas, PhD at University of Miami. The trial plans to enroll 28 participants.