Gut-Brain Neural Coupling in Spinal Cord Injury
University of Miami · NCT07052344
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–70 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 28
- US sites recruiting
- 1
- Study start
- October 29, 2025
- Record last updated
- July 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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).
Being studied: Preload condition; Ad-libitum control condition
Conditions: SCI - Spinal Cord Injury
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
University of Miami - Miami Project to Cure Paralysis
Miami, FL 33136
Site contact: Gary J Farkas, PhD · 305-243-4518 · gjf50@med.miami.edu
Study contacts (from the official record)
- Guillermo Mederos · 305-243-4518 · gxm1228@med.miami.edu
- Gary J Farkas, PhD · 305-243-4518 · gjf50@med.miami.edu
Similar studies in Florida
All healthy volunteers studies in Florida →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study of LY4302814 in Healthy Participants
Eli Lilly and Company
- Location
- Daytona Beach, FL
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
Pfizer
- Location
- Orlando, FL + 3 other US sites
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
BioCorRx Pharmaceuticals Inc
- Location
- Miami, FL
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Arcutis Biotherapeutics, Inc.
- Location
- Miami, FL + 6 other US sites
- Eligibility basics
- Ages 18–65