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Spinal Cord Injury's Gut-Brain Neural Connection Study

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Study AimThis study explores the gut-brain neural connection in individuals with spinal cord injuries by assessing phase amplitude coupling (PAC) strength, which measures the interaction between stomach electrical signals and brain rhythms.
What is being tested

Preload condition

+ Ad-libitum control condition
Other
Who is being recruted

Central Nervous System Diseases
+3

+ Nervous System Diseases
+ Spinal Cord Diseases
From 18 to 70 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorUniversity of Miami
Study ContactGuillermo MederosMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 29, 2025Actual date on which the first participant was enrolled.

This study explores how eating affects the brain and stomach in people who have spinal cord injuries compared to those who do not. It aims to understand the connection between the gut and the brain, which could inform better treatment options or care practices for individuals with spinal cord injuries. By examining these interactions, researchers hope to gain insights that could lead to improved health outcomes for individuals with these injuries. Participants in the study will eat food, and researchers will monitor the activity in their brain and stomach. This involves measuring how these organs respond and interact after eating. The study does not specify any potential risks or benefits, but it aims to gather basic scientific knowledge that could be useful in the future for developing treatments or interventions.

Official TitleGut-Brain Neural Coupling in Spinal Cord Injury 
NCT07052344
Principal SponsorUniversity of Miami
Study ContactGuillermo MederosMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
28 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries
Trauma, Nervous System
Criteria
9 inclusion criteria required to participate
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).

Show More Criteria

21 exclusion criteria prevent from participating
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).
Do not meet the inclusion criteria.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will be in this group for up to 2 weeks.

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

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.
Group II
Active Comparator
Participants will be in this group for up to 2 weeks.

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 Objectives
Primary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
University of Miami - Miami Project to Cure ParalysisMiami, United StatesSee the location
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One Study Center
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