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Could hidden nerve damage explain pain in kids with developmental delays?

NCT ID NCT05645874

Knowledge-focused Sponsor: Heinrich-Heine University, Duesseldorf Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at whether children with neurodevelopmental disorders (like mitochondrial disease, cerebral palsy, or developmental delay) have fewer small nerve fibers in their skin, which could cause pain. Researchers took small skin biopsies from 203 children—some healthy and some with developmental disorders—and counted the nerve fibers. The goal was to establish normal reference values for children and see if nerve damage is an overlooked source of pain in this group.

What this could mean

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

What this could lead to
If successful, this could establish normal nerve density values for children and reveal whether small fiber neuropathy is a common, treatable cause of pain in kids with neurodevelopmental disorders.
What could go wrong
This is an observational study, not a treatment trial. It only measures nerve density and does not test any therapy, so it cannot directly improve symptoms.

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.

Participants

203 people

The number who actually took part.

Started

Feb 2022

Finished

Dec 2024

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.

Who is studied

1. Control (no underlying neurological disorder) individuals 2. Neurodevelopmental disorder\_Genetic cause known 3. Neurodevelopmental disorder\_Acquired (cause known, for example perinatal asphyxia or intracranial bleeding) 4. Neurodevelopmental disorder\_Cause unknown

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

control patients Inclusion Criteria: * Elective surgical intervention from lower leg * Interest to participate in the study, informed consent * Unremarkable neurological development Exclusion Criteria: * Clinical signs of polyneuropathy, autonomic dysfunction * Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology Neurodevelopmental patients Inclusion Criteria: * Neurodevelopmental problems (developmental delay, muscular hypotonia, seizures, ataxia,...) with age of onset before the age of 18 years * Interest to participate in the study, informed consent Exclusion Criteria: * Known polyneuropathy * Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology

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Conditions

The condition(s) this trial relates to.

cerebral palsy developmental disability inborn mitochondrial metabolism disorder mitochondrial disease neurodevelopmental disorder primary erythermalgia Small Fiber Neuropathy

As listed by the trial registrant

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

Cerebral palsy Developmental delay (disorder) Mitochondrial diseases Small fiber neuropathy

Contacts and locations

Locations

  • University Hospital Düsseldord, Department of General Pediatrics, Neonatology and Pediatric Cardiology

    Düsseldorf, 40225, Germany

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