Gut–brain connections after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.