Recruiting

Spinal Cord Injury's Gut-Brain Neural Connection Study

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Study Aim

This 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: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 29, 2025

Actual 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: January 28, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesSpinal Cord InjuriesWounds and InjuriesTrauma, Nervous System

Criteria

9 inclusion criteria required to participate
At least 12 months post-SCI, denoting chronic injury
On a bowel care program every day or every other day (self-report).
Sex, male or female.
Weight-stable (±3 kg) for the preceding 3 months (self-report).
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21 exclusion criteria prevent from participating
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).
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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.

Group II

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

Study Objectives

Primary Objectives

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 Paralysis

Miami, United StatesSee the location
Recruiting
One Study Center