Actively Recruiting
Gut-Brain Neural Coupling in Spinal Cord Injury
Led by University of Miami · Updated on 2025-11-25
28
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Gut-Brain Neural Coupling in Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Male or female participants
- Weight stable within ±3 kg for the past 3 months (self-reported)
- Physically inactive, not meeting weekly activity guidelines of less than 150 minutes per week for the past 3 months (self-reported)
- Fluent in written and spoken English
- At least 12 months post spinal cord injury (SCI)
- Complete ASIA Impairment Scale A or motor-incomplete AIS B tetraplegia at or above C8 lesion
- Able to self-feed (self-reported)
- On a bowel care program every day or every other day (self-reported)
You will not qualify if you...
- Do not meet the inclusion criteria
- Current or regular smoker as defined by CDC/NIH (smoked 100 cigarettes in lifetime and currently smokes daily or every other day) (self-reported)
- Currently dieting or trying to gain or lose weight
- Vagus or recurrent laryngeal nerve injury (self-reported)
- Uncontrolled thyroid disease without medication treatment (self-reported)
- Diabetes (type 1 or 2) or currently taking anti-diabetic or GLP-1/dual agonist medications (self-reported)
- Gastrointestinal diseases such as inflammatory bowel disease, celiac disease, irritable bowel syndrome, gastroesophageal reflux disease, peptic ulcer disease, chronic pancreatitis, liver cirrhosis, or history of gastrointestinal surgery
- Swallowing disorder (self-reported)
- History of bariatric surgery
- Food allergies, dislikes, or dietary restrictions such as veganism (self-reported)
- Allergy to adhesives (self-reported)
- Open abdominal wounds or non-intact abdominal skin
- Current use of probiotics or prebiotics (self-reported)
- Current use of medications affecting appetite, body weight, or bowel function such as prokinetics, antiemetics, narcotic analgesics, anticholinergics, anti-inflammatories, antipsychotics, or anti-obesity agents (self-reported)
- Pregnant or breastfeeding women
- Non-adults (infants, children, teenagers)
- Adults unable to consent
- Prisoners
- Less than 12 months post spinal cord injury
- Motor-incomplete AIS C or D paraplegia (SCI below C8 lesion)
- Ventilator dependence (self-reported)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
Guillermo Mederos
CONTACT
G
Gary J Farkas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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