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Light-Based brain cap could replace radiation scans for kids

NCT ID NCT05642221

Knowledge-focused Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 17, 2026 · Updated 5 times

Summary

This study tested whether two light-based technologies, fNIRS and DCS, can safely measure brain activity in children with rare neurocognitive disorders like Niemann-Pick disease and Smith-Lemli-Opitz syndrome. 73 participants, including healthy volunteers, wore a cap with lights and sensors while doing computer tasks. The goal was to see if these scans are practical and safe, not to treat any condition.

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 provide a safer, radiation-free way to study brain activity in children with neurocognitive disorders.
What could go wrong
This is a small pilot study (73 participants) focused on feasibility, not treatment. It may not show clear differences between groups or lead to clinical use.

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

73 people

The number who actually took part.

Started

Jan 2023

Finished

Apr 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

individuals 6 months and older without known health or medical issues (i.e. healthy volunteers), and individuals with known neurocognitive disorders (i.e. affected). Healthy volunteers will be age- and sex-matched to the affected cohort

Ages

6 months to 110 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: * For both study populations (Affected and Typically Developing group): * Male or female, aged 6 months and up * English is the primary language spoken at home * For study population (Affected group): --Neurocognitive-related conditions including SLOS, CLN3, CTD, NPC and PMS. * For controls (Typically Developing Group): * In good general health as determined by medical history and physical exam EXCLUSION CRITERIA: * For both study populations (Affected and Typically Developing group): * Any condition that may affect placement of the fNIRS-DCS * Past or present vascular disease * Traumatic loss of consciousness in the last year * Any condition which, in the opinion of the investigator, increases risk of participation or affects adherence to the protocol * For controls (Typically Developing Group): * Known or suspected cognitive impairment * Known history of MRI abnormality * Current use of psychotropic medications

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Conditions

The condition(s) this trial relates to.

cognitive disorder creatine transporter deficiency juvenile neuronal ceroid lipofuscinosis Neuronal Ceroid-Lipofuscinoses Niemann-Pick disease type A Niemann-Pick disease, type C1 Phelan-McDermid syndrome Smith-Lemli-Opitz syndrome

As listed by the trial registrant

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

Creatine transporter deficiency Juvenile neuronal ceroid lipofuscinosis Niemann-Pick disease type C1 Smith-Lemli-Opitz syndrome

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.