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Scientists probe pain in people with intellectual disability

NCT ID NCT05473429

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13 times

Summary

This study compares brain responses to heat, cold, brushing, and mild electric shocks in people with and without intellectual disability. Researchers use brain scans and heart rate monitors to measure pain. The goal is to better understand how pain is felt in this group, especially for those who cannot speak.

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 study could help doctors better recognize and treat pain in people with intellectual disability who cannot communicate verbally.
What could go wrong
This is an early observational study, not testing a treatment. It may not lead to immediate changes in care, and results may not apply to all individuals with intellectual disability.

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 215 people

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

Started

Mar 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Ages

8 to 30 years

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.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: For All Participants * Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, aged 8-30 years of age. * Agreement to avoid use of analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances and alcohol within 2 days prior to enrollment and during study participation. Healthy Adult Controls * IQ 85 OR General Adaptive Composite ABAS-3 score above 85 * Must be fluent in the English Language. Healthy Children * OR ABAS-3 score above 85. * Must be fluent in the English Language. Patients -Diagnosis of Intellectual Disability. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: All participants * NIH employees or children of NIH employee who subordinate to an investigator in this study will be excluded. This will ensure that participation or refusal to participate cannot be perceived as having any beneficial or adverse effects on their employment. There will be no direct solicitation of employees or of employees' children by the employee's supervisor. * Allergic reactions to EEG water based gel. * History of concussions in individuals with an IQ\>85. * Uncontrolled seizures. * Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy. * For healthy volunteers only - known history of neurological, psychiatric or pain disorders. * History of head injury resulting in prolonged loss of consciousness in individuals with an IQ\>85. Healthy Children -Children who have been diagnosed with neurodevelopmental disorders or treated in early intervention programs. Patients -Subjects who are on opioids, NSAID, gabapentin, or pregabalin chronically.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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