Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder
NCT ID: NCT06233279
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-11-15
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group
Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Charge-Balanced, Symmetric Nerve Stimulation
Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Control Group
Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Sham Stimulation
Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Interventions
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Charge-Balanced, Symmetric Nerve Stimulation
Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Sham Stimulation
Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with autism spectrum disorder
* A person who has a total intelligence index of 70 or higher and has no problems with basic language communication
* A person who agrees not to use any medical device other than this clinical trial medical device during the clinical trial period
* A person who does not take a concurrent drug from screening to the end of the study, or who can maintain the concurrent drug during the clinical trial period without any change or addition
* Voluntary written consent to participate in this clinical trial
Exclusion Criteria
* If it is difficult to understand the contents of treatment due to the limitation of intelligence index or language ability, and if it is difficult to conduct a study
* When there is a risk of clinically significant behavioral problems, emotional control problems, psychiatric symptoms, self-harm, or other harm that can affect the treatment process
* Psychiatric hospitalization history
* A person with acute or chronic medical or mental illness
* A person with a history of seizures
* Serious trauma and surgery within 1 month
* A person who is deemed to have a problem with the adhesion of electrodes due to inflammatory reactions or other dermatological problems on the skin around the forehead to which electrodes of clinical trial medical devices are attached
* If it is need to take sleep medications \[benzodiazepine, melatonin, trazodone\] (\*However, it is participated after having a washout period of at least two weeks.)
* A person who is deemed to have other reasons for prohibition of use of clinical trial medical devices (including heart-related problems, seizures, metal or electronic devices implanted in the head, people with unknown pain, pacemaker transplant, etc.)
* When it is determined by the researcher that it is difficult for the subject to continue voluntary participation in the study due to the lack of cooperation and motivation for treatment
* Other cases where it is deemed difficult to participate in the study by the researcher's judgment
7 Years
12 Years
ALL
No
Sponsors
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Nu Eyne Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hee Jeong Yoo, Ph. D., MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hee Jeong Yoo, Ph. D., MD.
Role: primary
Other Identifiers
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NE_PSY_001
Identifier Type: -
Identifier Source: org_study_id
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