Intellectual DisabilityNCT05473429
Characterization of Nociception Phenotype in Individuals With Intellectual Disability
A study testing TSA2 Thermosensory Stimulator in people with Intellectual Disability, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- TSA2 Thermosensory Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 6 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- Healthy Adult Controls
- IQ 85 OR General Adaptive Composite ABAS-3 score above 85
- Must be fluent in the English Language.
- Healthy Children
- IQ above 85 OR ABAS-3 score above 85.
- Must be fluent in the English Language.
- Patients
- -Diagnosis of Intellectual Disability.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Characterization of the Nociception Phenotype in Individuals With Intellectual Disability
Background:
People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID.
Read more
Objective:
To compare brain responses to unpleasant stimuli in people with and without ID.
Eligibility:
People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed.
Design:
The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead.
Participants will take a test to measure their level of ID. They will have a physical exam.
Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot.
Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers.
Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces.
Read the detailed description
STUDY DESCRIPTION:
The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability (ID) compared to healthy controls.
OBJECTIVES:
Primary Objective:
To characterize brain activation patterns using electroencephalography (EEG) and cerebral functional-near-infrared spectroscopy (fNIRS) in response to innocuous and noxious stimulation in individuals with ID (ages, 8-30 years), compared with the brain activation pattern observed in healthy controls.
We hypothesize that compared to healthy controls, individuals with ID will present decreases in oxygenated hemoglobin (measured by fNIRS) in pain responsive regions (e.g., secondary somatosensory cortex), in response to standardized noxious stimuli (heat, cold, and electrical). In addition, individuals with ID will also present smaller suppression of oscillation in alpha and beta frequencies (measured by EEG at central sites) in response to these stimuli.
Exploratory Objective:
To determine the relationship between brain activation patterns to innocuous and noxious stimuli with physiological and behavioral responses to the same stimuli, in individuals with ID. We hypothesize that decreased oxygenated hemoglobin in response to noxious stimuli in the secondary somatosensory cortex, as well as smaller suppression of oscillations in alpha and beta frequencies at central sites in individuals with ID will correlate with changes in heart rate, galvanic skin response and pupil dilation. In addition, we hypothesize that decreased oxygenated hemoglobin to noxious thermal and electrical stimuli in the secondary somatosensory cortex, as well as smaller suppression of oscillations in alpha and beta frequencies will also be associated with behavioral observations (e.g. vocal, social and changes in facial, body and extremities activity).
ENDPOINTS:
Primary Endpoints:
- fNIRS response to innocuous and noxious stimuli: oxygenated and deoxygenated hemoglobin concentration measured in the secondary somatosensory cortex.
- EEG response to innocuous and noxious stimuli: Alpha and beta oscillations measured at central sites (C3 and C4).
- Physiological responses to innocuous and noxious stimulation (heart rate, respiratory rate, galvanic skin response, and pupillary changes).
- Behavioral responses to noxious stimulation (e.g. vocal, social and changes in facial, body and extremities activity).
- Conditions
- Intellectual Disability
- Being tested
- TSA2 Thermosensory Stimulator
- Keywords
- EEG, fNIRS, Pain Thresholds, Brain Signals, Quantitative Sensory Testing
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSA2 Thermosensory StimulatorDevice
TSA thermal analyzer uses the thresholds for four sub-modalities to measure thermal sensory threshold. This device is capable of heating or cooling the skin as needed to detect heat and cold tolerance and to deliver thermal stimuli.
| Study group | Role | What they receive |
|---|---|---|
| 1/ID patients | Experimental | ID Patients Receives: Device: TSA2 Thermosensory Stimulator |
| 2/Healthy controls | Active comparator | Healthy controls Receives: Device: TSA2 Thermosensory Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide quantitative measure of pain perception
- fNIRS: oxygenated hemoglobin. b.EEG: Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis. c. Pain thresholds (electrical perception threshold; electric tolerance threshold) d. Correlation between brain signals (oxygenated hemoglobin; theta, alpha, beta and gamma oscillations) to pain with behavioral assessments of pain, general functioning and sensory processing
Measured: End of study
Secondary outcomes (1)
Provides measure of pain among non-communicating individuals
- NCCPC-R and other behavioral measurements of pain administered during QST; b. fNIRS: oxygenated hemoglobin. c. EEG:Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start27 Mar 2026
- Primary completion6 Oct 2027 (estimated)
- Study completion6 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Zenaide MN Quezado, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473429
- Sponsor's protocol ID
- 10000417
- Other IDs
- 000417-CC
- Status last verified
- 19 Oct 2026
- First submitted
- 23 Jul 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Nociception Phenotype in Individuals With Intellectual Disability
- ClinicalTrials.gov ID
- NCT05473429
- Acronym / sponsor ID
- 10000417
- Conditions
- Intellectual Disability
- Keywords
- EEG, fNIRS, Pain Thresholds, Brain Signals, Quantitative Sensory Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 6 Oct 2027 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID.
Objective:
To compare brain responses to unpleasant stimuli in people with and without ID.
Eligibility:
People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed.
Design:
The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead.
Participants will take a test to measure their level of ID. They will have a physical exam.
Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot.
Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers.
Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces.
Detailed description
STUDY DESCRIPTION:
The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability (ID) compared to healthy controls.
OBJECTIVES:
Primary Objective:
To characterize brain activation patterns using electroencephalography (EEG) and cerebral functional-near-infrared spectroscopy (fNIRS) in response to innocuous and noxious stimulation in individuals with ID (ages, 8-30 years), compared with the brain activation pattern observed in healthy controls.
We hypothesize that compared to healthy controls, individuals with ID will present decreases in oxygenated hemoglobin (measured by fNIRS) in pain responsive regions (e.g., secondary somatosensory cortex), in response to standardized noxious stimuli (heat, cold, and electrical). In addition, individuals with ID will also present smaller suppression of oscillation in alpha and beta frequencies (measured by EEG at central sites) in response to these stimuli.
Exploratory Objective:
To determine the relationship between brain activation patterns to innocuous and noxious stimuli with physiological and behavioral responses to the same stimuli, in individuals with ID. We hypothesize that decreased oxygenated hemoglobin in response to noxious stimuli in the secondary somatosensory cortex, as well as smaller suppression of oscillations in alpha and beta frequencies at central sites in individuals with ID will correlate with changes in heart rate, galvanic skin response and pupil dilation. In addition, we hypothesize that decreased oxygenated hemoglobin to noxious thermal and electrical stimuli in the secondary somatosensory cortex, as well as smaller suppression of oscillations in alpha and beta frequencies will also be associated with behavioral observations (e.g. vocal, social and changes in facial, body and extremities activity).
ENDPOINTS:
Primary Endpoints:
- fNIRS response to innocuous and noxious stimuli: oxygenated and deoxygenated hemoglobin concentration measured in the secondary somatosensory cortex.
- EEG response to innocuous and noxious stimuli: Alpha and beta oscillations measured at central sites (C3 and C4).
- Physiological responses to innocuous and noxious stimulation (heart rate, respiratory rate, galvanic skin response, and pupillary changes).
- Behavioral responses to noxious stimulation (e.g. vocal, social and changes in facial, body and extremities activity).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/ID patients | Experimental | Device: TSA2 Thermosensory StimulatorID Patients |
| 2/Healthy controls | Active comparator | Device: TSA2 Thermosensory StimulatorHealthy controls |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSA2 Thermosensory StimulatorTSA thermal analyzer uses the thresholds for four sub-modalities to measure thermal sensory threshold. This device is capable of heating or cooling the skin as needed to detect heat and cold tolerance and to deliver thermal stimuli. | Device | 1/ID patients, 2/Healthy controls |
Primary outcome
Provide quantitative measure of pain perception
Time frame: End of study
a. fNIRS: oxygenated hemoglobin. b.EEG: Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis. c. Pain thresholds (electrical perception threshold; electric tolerance threshold) d. Correlation between brain signals (oxygenated hemoglobin; theta, alpha, beta and gamma oscillations) to pain with behavioral assessments of pain, general functioning and sensory processing
1 secondary outcome
Provides measure of pain among non-communicating individuals
Time frame: End of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zenaide MN Quezado, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSA2 Thermosensory Stimulator in people with Intellectual Disability, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zenaide MN Quezado, M.D. ((301) 827-1271, zquezado@cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provide quantitative measure of pain perception (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.