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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for sensory stimulation in individuals with intellectual disability?

Research shows that using tools like the Pain Assessment in Impaired Cognition (PAIC-15) and the Facial Action Coding System (FACS) can reliably detect and quantify pain in individuals with intellectual disabilities. These tools help in understanding pain responses, which is crucial for effective pain management in this group. ^{1 2 3 4 5}

Is sensory stimulation safe for individuals with intellectual disabilities?

The studies reviewed focus on assessing pain and sensory responses in individuals with intellectual disabilities, but they do not report any specific safety concerns related to the sensory stimulation methods used. ^{1 2 3 5 6}

How does sensory stimulation treatment differ from other treatments for intellectual disability?

Sensory stimulation treatment for intellectual disability is unique because it focuses on using different sensory modalities like touch and temperature to assess and respond to sensory and pain experiences, which is crucial for individuals with communication challenges. This approach is different from standard treatments as it emphasizes understanding and measuring behavioral responses to sensory inputs, rather than relying solely on verbal communication or medication. ^{2 3 5 7 8}

Research Team

Zenaide MN Quezado, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating a sham-controlled sensory-testing protocol for nonverbal adults with neurodevelopmental disorders: self-injury and gender effects. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Physiological and Behavioral Responses to Calibrated Noxious Stimuli Among Individuals with Cerebral Palsy and Intellectual Disability. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Perspectives on pain and intellectual disability. [2011]

5. Switzerland 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A quantitative somatosensory testing of pain threshold in individuals with mental retardation. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Quantitative somatosensory thermotest. A key method for functional evaluation of small calibre afferent channels. [2022]

8. United States 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. [2023]