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Brain waves vs. belly pain: neurofeedback tested for IBD-related discomfort

NCT ID NCT07473076

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether neurofeedback — a type of brain training using real-time brainwave feedback — can reduce musculoskeletal pain in people with chronic inflammatory bowel disease (IBD). Eighty adults with IBD and persistent pain will be randomly assigned to either 8 sessions of neurofeedback or standard psychological care. The main goal is to see if pain intensity drops more with neurofeedback.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neurofeedback therapy (alpha/theta training)
What this could lead to
If it works, this could offer a drug-free way to manage chronic pain in people with inflammatory bowel disease.
What could go wrong
This is an early-stage trial with only 80 participants. The placebo group gets standard psychological care, so any benefit over that may be small. Pain is subjective, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 65 years. * Patients diagnosed with IBD for at least six months. * Ability to understand and provide signed informed consent. * Patients with IBD and a prior diagnosis of axial/peripheral spondyloarthritis without objective evidence of joint inflammation (clinical and/or instrumental, as per rheumatological assessment), but with persistent musculoskeletal pain (VAS scale score \>50/100 in the last week; HAQ-DI score \>0.5; FACIT Fatigue Scale score ≥40; NPS score \>1) Or • Patients with IBD and musculoskeletal pain who do not meet the criteria for the diagnosis of spondyloarthritis or other inflammatory arthritis (as per rheumatological assessment), but with persistent musculoskeletal pain (VAS scale score \>5/10 in the last week; HAQ-DI score \>0.5; FACIT Fatigue Scale score ≥40; NPS score \>1). Exclusion Criteria: * Patients under 18 or over 65 years of age. * Patients affected by Inflammatory Bowel Disease-Unclassified (IBD-U). * Inability to provide informed consent. * Refusal to provide informed consent. * Presence of severe language deficits. * Patients diagnosed with axial/peripheral spondyloarthritis with objective evidence of joint inflammation (clinical and/or instrumental, as per rheumatological assessment). * Patients with other comorbidities that may invalidate rheumatological evaluation (Substance Use Disorder, Schizophrenia Spectrum and other Psychotic Disorders, Diabetes Mellitus, other rheumatological diseases).

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Conditions

The condition(s) this trial relates to.

agnosia inflammatory bowel disease Musculoskeletal Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel diseases

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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