Sensory Stimulation for Intellectual Disability

Overseen By Zenaide MN Quezado, M.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Must not be taking: Opioids, NSAID, Gabapentin, Pregabalin

Disqualifiers: Uncontrolled seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with and without intellectual disabilities (ID) respond to various physical sensations, such as heat and cold, to better understand pain in those with ID. Participants will undergo tests to measure brain activity and answer questions about their pain experiences and sensory responses. The study will use the TSA2 Thermosensory Stimulator, a device that applies controlled temperature changes. Individuals aged 8 to 30 with diagnosed intellectual disabilities and healthy volunteers without ID are invited to participate. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance pain management for individuals with intellectual disabilities.

Will I have to stop taking my current medications?

The trial requires participants to avoid using pain relievers, NSAIDs (non-steroidal anti-inflammatory drugs), caffeine, illicit substances, and alcohol for 24 hours before the procedures and during the study. If you are taking opioids, NSAIDs, gabapentin, or pregabalin regularly, you cannot participate in the trial.

What prior data suggests that this sensory stimulation method is safe for individuals with intellectual disability?

Research has shown that the TSA2 Thermosensory Stimulator, used in this study, provides controlled heat or cold sensations to examine pain perception. Tests on healthy individuals have assessed its impact on pain sensitivity. The device allows precise temperature control, aiding researchers in understanding reactions to heat.

While specific safety data for individuals with intellectual disabilities is lacking, the stimulator has been used in numerous research settings without reports of serious side effects. This suggests general safety, particularly since it is used in short, controlled sessions. Participants can expect to feel heat or cold, which is integral to the study's aim of understanding pain responses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore sensory stimulation as a way to better understand and potentially improve treatment for individuals with intellectual disabilities (ID). Unlike current treatments that primarily focus on behavioral interventions or medications to manage symptoms, this approach investigates how people with ID experience sensory inputs differently, specifically through a new technique using the TSA2 Thermosensory Stimulator. By characterizing the nociception phenotype—essentially how individuals perceive pain and temperature—researchers hope to uncover insights that could lead to more personalized and effective interventions. This could open up new avenues for enhancing the quality of life for individuals with ID, making it a promising area of research.

What evidence suggests that this trial's treatments could be effective for intellectual disability?

Research shows that the TSA2 Thermosensory Stimulator accurately measures pain perception by controlling temperature. This device rapidly changes temperatures to assess pain reactions. In this trial, researchers will use the TSA2 to compare how individuals with intellectual disabilities and healthy controls respond to varying levels of heat or cold. Studies have proven its reliability in measuring pain levels, which is crucial for understanding pain in individuals with intellectual disabilities. This understanding may offer insights into managing pain for this population. ^{1 2 3 6 7}

Who Is on the Research Team?

Zenaide MN Quezado, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

This trial is for individuals aged 8 to 30 with intellectual disability (ID) and healthy volunteers without ID. Participants must speak English fluently, agree not to use certain medications or substances before the study, and be willing to follow all procedures. Pregnant women, those with neurological issues or a history of severe head injury are excluded.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient

For Healthy Adult Controls: IQ above 85, Must be fluent in the English Language

Exclusion Criteria

I have seizures that are not controlled by medication.

I am a healthy volunteer without any history of neurological, psychiatric, or pain disorders.

My child has a neurodevelopmental disorder or has been in early intervention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants undergo tests to measure their level of intellectual disability and physical exams. Brain activity is measured using EEG and fNIRS in response to stimuli.

1 visit (up to 4 hours) or up to 5 shorter visits

1 visit (in-person) or up to 5 shorter visits (in-person)

Follow-up

Participants are monitored for any adverse effects and data is collected for analysis.

End of study

What Are the Treatments Tested in This Trial?

Interventions

• Characterization of Nociception Phenotype in Individuals With Intellectual Disability
• Physical Exam
• TSA2 Thermosensory Stimulator

Trial Overview The study tests how people with and without ID react to pain by using a TSA2 Thermosensory Stimulator. It involves one visit up to four hours long where brain activity in response to heat, cold, brushing, and mild electrical stimuli is measured.

How Is the Trial Designed?

Group I: 1/ID patients Experimental Treatment 1 Intervention

ID Patients

Group II: 2/Healthy controls Active Control 1 Intervention

Healthy controls

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Published Research Related to This Trial

In a study of 16 children with global developmental delay, those experiencing chronic pain showed a significantly higher density of epidermal nerve fibers, suggesting a link between nerve fiber density and pain perception.

The study demonstrated that increased epidermal nerve fiber density was associated with greater vocal reactivity during sensory tests, indicating that sensory processing and pain responses can be effectively assessed in children at risk for developmental disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying quantitative sensory testing to investigate behavioral reactivity in a pediatric global developmental delay sample: Relation to peripheral innervation and chronic pain outcomes. Symons, FJ., Burkitt, CC., Wilcox, G., et al.[2023]

Facial expressions and subjective self-reports effectively differentiate between painful and non-painful states in individuals with intellectual and developmental disabilities (IDD), suggesting these methods can be used for pain assessment in this population.

Individuals with IDD showed heightened facial responses and lower heart rate variability during painful stimuli compared to healthy controls, indicating they may have increased sensitivity to pain that needs to be addressed in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific Behavioral Responses Rather Than Autonomic Responses Can Indicate and Quantify Acute Pain among Individuals with Intellectual and Developmental Disabilities. Defrin, R., Benromano, T., Pick, CG.[2021]

The quantitative somatosensory thermotest (QST) effectively measures sensory function related to temperature perception and pain in 465 individuals, revealing 13 abnormal patterns of thermal sensation, which can indicate specific types of sensory dysfunction.

QST can detect conditions like thermal hypoaesthesia and hyperalgesia even when traditional sensory tests show normal results, suggesting that it should be included in routine neurological assessments to identify underlying pathophysiologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative somatosensory thermotest. A key method for functional evaluation of small calibre afferent channels. Verdugo, R., Ochoa, JL.[2022]

A study involving 44 adults with moderate to severe intellectual disabilities demonstrated that a sham-controlled sensory-testing protocol effectively distinguished between active and sham sensory stimulation, indicating that these individuals can respond to tactile stimuli.

The findings revealed that females were generally more expressive than males regarding their facial responses to sensory stimuli, and individuals exhibiting self-injurious behavior showed heightened expressiveness, highlighting the importance of valid measurement procedures for assessing pain in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a sham-controlled sensory-testing protocol for nonverbal adults with neurodevelopmental disorders: self-injury and gender effects. Symons, FJ., Harper, V., Shinde, SK., et al.[2021]

The Pain Assessment in Impaired Cognition (PAIC-15) tool effectively measures pain behaviors in individuals with intellectual and developmental disabilities (IDD), showing a clear response to pressure stimuli, with higher scores in the IDD group compared to typically developing controls.

The PAIC-15 was successfully translated into Arabic, demonstrating high reliability between the English and Arabic versions, making it a valuable resource for Arabic-speaking professionals in assessing pain in individuals with IDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Behavior of People with Intellectual and Developmental Disabilities Coded with the New PAIC-15 and Validation of Its Arabic Translation. Defrin, R., Beshara, H., Benromano, T., et al.[2021]

Individuals with cerebral palsy and intellectual disability (CPID) show heightened responses to pain, as evidenced by increased pain ratings and facial expressions compared to healthy controls.

Facial expressions and self-reports are effective indicators of pain intensity in CPID individuals, while autonomic responses (like heart rate) do not correlate with pain levels, suggesting that the pyramid scale for self-reporting is a suitable tool for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and Behavioral Responses to Calibrated Noxious Stimuli Among Individuals with Cerebral Palsy and Intellectual Disability. Benromano, T., Pick, CG., Merick, J., et al.[2018]

Individuals with intellectual disability (ID) have historically been overlooked in pain research, leading to misconceptions about their ability to experience pain, which has resulted in inadequate care and consideration during medical procedures.

Emerging interdisciplinary research is beginning to reshape our understanding of pain in individuals with ID, focusing on improving assessment methods and addressing biases, which could significantly enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on pain and intellectual disability. Symons, FJ., Shinde, SK., Gilles, E.[2011]

Individuals with mild mental retardation (MR) and Down's syndrome have a lower heat-pain threshold compared to controls, indicating they may be more sensitive to heat-pain than previously thought.

The study suggests that using reaction time-free methods, like the method of levels (MLE), is more effective for measuring pain sensitivity in individuals with MR due to their slower reaction times and conduction velocities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quantitative somatosensory testing of pain threshold in individuals with mental retardation. Defrin, R., Pick, CG., Peretz, C., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-intellectual-disability-7-2022-84883

Sensory Stimulation for Intellectual Disability Trial Overview The study tests how people with and without ID react to pain by using a TSA2 Thermosensory Stimulator. It involves one visit up to four hours ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10860393/

Optimizing Temporal Summation of Heat Pain Using a ... This study sought to identify optimal parameters for evoking TS-heat in healthy participants with a commercially available constant contact heat stimulator.

3. researchgate.net researchgate.net/publication/363703034_Test-Retest_reliability_and_concurrent_validity_of_novel_nerve_testing_device_for_thermal_detection_and_thermal_pain_thresholds

(PDF) Test-Retest reliability and concurrent validity of novel ... Test-retest reliability of the NNTD and its concurrent validity compared to the current technology (Medoc TSA-2, Advanced Thermosensory ...

4. medoc-web.com medoc-web.com/tsa-2

TSA2 - Advanced Thermosensory Stimulator, Thermal Pain ... Precise thermal pain stimulation temperature control. External Control programming capability. Rapid thermal stimulation rates- up to 13°C/sec.

5. elifesciences.org elifesciences.org/articles/90634

Statistical learning shapes pain perception and prediction ... We used the Medoc Advanced Thermosensory Stimulator 2 (TSA2) (Medoc Advanced Medical Systems, 2022) to deliver thermal stimuli using the CHEPS ...

6. udspace.udel.edu udspace.udel.edu/bitstreams/ff8df471-68df-45be-a0de-a9262cdd0dd1/download

comparison between the - UDSpace - University of Delaware Bland-Altman plots were created for every test conducted on the Pathway and TSA2. These plots include all the average data values on the left and right legs ...

7. degruyterbrill.com degruyterbrill.com/document/doi/10.1515/sjpain-2023-0093/html?lang=en&srsltid=AfmBOoou8k5xmpyhzScy046KF3iVeAh17-EccYSJotcRYJrDULzEFaIF

Concurrent validity of dynamic bedside quantitative ... This study investigated the concurrent validity of two bedside protocols for CPM and TSP in comparison to a respective reference protocol.