UMIN-ICDS Clinical Trial

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

Autism spectrum disorder

Classification by specialty

Psychiatry

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ozeki@belle.shiga-med.ac.jp

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

Email

fumi@sums-psychiatry.com

Institute

Shiga University of Medical Science

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board, Shiga University of Medical Science

Address

Tsukinowa-cho, Seta, Otsu-city, Shiga

Tel

077-548-3576

Email

hqrec@belle.shiga-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

05

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000058138