SCI - Spinal Cord InjuryNCT07052344
Gut-Brain Neural Coupling in Spinal Cord Injury
A study testing Preload condition in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Preload condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- At least 12 months post-SCI, denoting chronic injury
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- 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).
Who cannot join
- 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).
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- 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
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136
Gary J Farkas, PhD, 305-243-4518, gjf50@med.miami.edu
Guillermo Mederos, 305-243-3543, gxm1228@med.miami.edu
About this study
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
- SCI - Spinal Cord Injury
- Being tested
- Preload condition, Ad-libitum control condition
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preload conditionOther
Participants will consume a fixed compulsory preload meal of Campbell's Tomato soup (~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load condition visit will be up to 6 hours
Ad-libitum control conditionOther
Participants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Pre-load Condition Meal Group | Experimental | Participants will be in this group for up to 2 weeks. Receives: Other: Preload condition; Other: Ad-libitum control condition |
| Ad-libitum Condition Meal Group | Active comparator | Participants will be in this group for up to 2 weeks. Receives: Other: Ad-libitum control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase amplitude coupling (PAC) strength
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.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start29 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Farkas, University of Miami
- Investigators
- Gary J Farkas, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052344
- Sponsor's protocol ID
- 20250237
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-Brain Neural Coupling in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07052344
- Acronym / sponsor ID
- 20250237
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-load Condition Meal Group | Experimental | Other: Preload condition, Other: Ad-libitum control conditionParticipants will be in this group for up to 2 weeks. |
| Ad-libitum Condition Meal Group | Active comparator | Other: Ad-libitum control conditionParticipants will be in this group for up to 2 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preload conditionParticipants will consume a fixed compulsory preload meal of Campbell's Tomato soup (~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load condition visit will be up to 6 hours | Other | Pre-load Condition Meal Group |
| Ad-libitum control conditionParticipants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours. | Other | Ad-libitum Condition Meal Group, Pre-load Condition Meal Group |
Primary outcome
Phase amplitude coupling (PAC) strength
Time frame: up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary J Farkas, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preload condition in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Mederos (305-243-4518, gxm1228@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase amplitude coupling (PAC) strength (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.