NCT07052344 · University of Miami
Gut-Brain Neural Coupling in Spinal Cord Injury
What this study is about
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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2025 · Source of record for eligibility and locations