Gut-Brain Neural Coupling in Spinal Cord Injury

This study is looking at how food affects brain and stomach activity in people with and without spinal cord injury (SCI). You would either eat a fixed meal of Campbell's Tomato soup followed by Stouffer's Macaroni and Cheese, or just the Stouffer's Macaroni and Cheese. Researchers will measure how your brain and stomach communicate (called "Phase amplitude coupling" or PAC strength) to understand these effects. The study is open to adults aged 18 to 70 who are generally healthy, physically inactive, and fluent in English. The current recruitment status is unclear, but the study plans to enroll 28 participants.

Study design: This is an interventional study with two different meal conditions. It plans to enroll 28 participants.
What's involved: You would have two visits, separated by up to two weeks. During these visits, you would consume specific meals.
Compensation: Not stated in the trial record.
Follow-up: Your brain and stomach activity will be measured for up to two weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Gut-Brain Neural Coupling in Spinal Cord Injury

Recruiting

NAAges 18–70InterventionalBasic science

University of Miami

~28 participants

Updated 2026-07-17 on ClinicalTrials.gov

What's tested:Preload conditionAd-libitum control condition

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Phase amplitude coupling (PAC) strength

Measured over up to 2 weeks

Conditions

SCI - Spinal Cord Injury

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Gary J Farkas, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Guillermo Mederos

[email protected]

305-243-4518

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

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.

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

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).

What this trial measures

Phase amplitude coupling (PAC) strengthup to 2 weeks
Gut-brain connectivity will be assessed using phase-amplitude coupling (PAC) to examine the interaction between gastric electrical oscillations and cortical rhythms. PAC will be calculated from electrophysiological raw data to produce one unitless value ranging from -1 to 1, for each subject. The higher the value, the greater the gut-brain connectivity/PAC strength.

Trialytics