Gut–brain connections after spinal cord injury
Gut-Brain Neural Coupling in Spinal Cord Injury
This research will test whether eating changes brain and stomach activity differently in adults with and without spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07052344 on ClinicalTrials.gov |
What this trial studies
Adults with and without spinal cord injury will attend in-person sessions where researchers compare a fixed preload meal with an ad-libitum (eat-as-you-like) condition while recording brain and stomach activity. The study enrolls people aged 18–70 who are weight-stable, physically inactive, and fluent in English, and excludes current smokers, people with diabetes, vagus nerve injury, or uncontrolled thyroid disease. Sessions occur at the University of Miami’s Miami Project to Cure Paralysis and involve repeated physiological measurements before and after food intake. Data will be compared between the spinal cord injury group and matched control participants to characterize differences in gut–brain signaling.
Who should consider this trial
Good fit: Adults aged 18–70 with spinal cord injury who are weight-stable, physically inactive (<150 minutes/week), non-smokers, not dieting, and able to attend in-person visits in Miami may be eligible.
Not a fit: People who are current smokers, have diabetes, vagus or recurrent laryngeal nerve injury, uncontrolled thyroid disease, are actively trying to change weight, or cannot travel to Miami are excluded and unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, this could help guide dietary strategies or therapies that target gut–brain signaling to improve symptoms in people with spinal cord injury.
How similar studies have performed: Previous work in people without spinal cord injury has shown that food intake alters brain and stomach activity, but applying these measurements specifically to spinal cord injury is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Miami, Florida
- University of Miami - Miami Project to Cure Paralysis — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Gary J Farkas, PhD — University of Miami
- Study coordinator: Guillermo Mederos
- Email: gxm1228@med.miami.edu
- Phone: 305-243-4518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.