UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050998 |
|---|---|
| Receipt number | R000058138 |
| Scientific Title | Quantitative Assessment of the Impact of Superficial Sensory Abnormalities on Psychiatric Symptoms in Autism Spectrum Disorder |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/11/07 10:33:06 |
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Basic information
Public title
Quantitative Assessment of the Impact of Superficial Sensory Abnormalities on Psychiatric Symptoms in Autism Spectrum Disorder
Acronym
Assessment of thermal pain perception in children with ASD
Scientific Title
Quantitative Assessment of the Impact of Superficial Sensory Abnormalities on Psychiatric Symptoms in Autism Spectrum Disorder
Scientific Title:Acronym
Assessment of thermal pain perception in children with ASD
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the Impact of thermal Sensation Abnormalities on Mood State and Parental Mental Status in Children with ASD: Based on the hypothesis that "a lowered superficial sensory threshold in children with ASD causes difficulties in life and worsens their mood state," this study clarifies the relationship between the thermal sensory thresholds of children with ASD and their own mood state and the mental state of their parents. In addition, we will compare the superficial sensory thresholds of children with ASD and non-ASD. This increases the potential for biological interventions to improve and maintain the mood state of children with ASD and the mental state of their parents.
In addition, the accumulation of evidence for the measurement of the thermal sensory thresholds will enable the objective assessment of sensory abnormalities that were previously only obtainable from subjective evaluations and complaints of the individuals. This objective evaluation is expected to facilitate sharing of the sense of difficulty in daily life with surrounding supporters and promote environmental adjustments.
Basic objectives2
Others
Basic objectives -Others
Quantitative Validation of Placebo Effects in ASD: In this study, we quantify the placebo analgesic effect using thermal stimuli for endogenous pain modulation in individuals with ASD and compare the results with age and gender-matched non-ASD individuals. Our goal is to investigate whether the placebo effect is effective for thermal stimuli and whether the effectiveness of placebo in ASD previously reported is specific to ASD. Furthermore, by identifying the background factors and symptoms associated with the placebo effect, we aim to take the first step towards more effective clinical applications of the placebo effect.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Objective Thermal Pain Assessment: Cold and warm detection thresholds: CDT/WDT, Cold and heat pain thresholds: CPT/HPT in Quantitative Sensory Testing
- Scores of Psychological Test: Sensory Profile: SP, Conners3, Social Responsiveness Scale: SRS-2, Child Behavior Checklist: CBCL, General Health Questionnaire: GHQ-28, Spence Children's Anxiety Scale: SCAS, Depression Self-Rating Scale for Children: DSRS-C, Short- Form McGill Pain Questionnaire-2: SF-MPQ-2, Pediatric Daytime Sleepiness Scale: PDSS
Key secondary outcomes
- Evaluation of Placebo Analgesia: placebo-QST
- Background of participants
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Case group: Individuals considered by clinicians to have a diagnosis of autism spectrum disorder, and their guardian.
Control group: Individuals who have never been diagnosed with a mental disorder, including developmental disabilities, and their guardian.
2. Age: Child 10 to 17 years old (At the time of registration)
3. Individuals who can understand the explanatory document of the study and obtain the written consent based on the free will of the patient and their guardian
Key exclusion criteria
1. Case group: Individuals with comorbid psychiatric disorders other than attention-deficit/hyperactivity disorder (ADHD) and intellectual developmental disorders (IDD)
2. Individuals with severe pain, acute trauma, or peripheral nerve paralysis in the non-dominant forearm for some reason
3. Individuals who were deemed unsuitable as study participants by the study's lead clinicians or co-clinicians
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ozeki |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
5202192
Address
Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL
077-548-2291
ozeki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Masuda |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
5202192
Address
Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL
077-548-2291
Homepage URL
fumi@sums-psychiatry.com
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Shiga University of Medical Science
Address
Tsukinowa-cho, Seta, Otsu-city, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Multiple regression analysis will be conducted using psychiatric symptom/behavior scores extracted from the results of psychological tests as the objective variable and thermal pain thresholds (and intra-individual variation in threshold estimates) as explanatory variables to clarify the impact of superficial sensory abnormalities on clinical symptoms.
- The thermal pain threshold and placebo analgesic effect will be compared between the autism spectrum disorder group and the control group.
- The model analysis will be conducted to determine whether the sensory abnormalities affect mood symptoms, problematic behaviors, and parental mental status independently of the core symptoms of ASD.
- Multiple regression analysis will be conducted using the placebo analgesic effect as the objective variable and the psychiatric symptom and behavior scores extracted from the psychological test results as explanatory variables to identify background factors and symptoms related to the placebo effect.
Management information
Registered date
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058138
