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The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are:
Participation spans 8-12 weeks and includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active eTNS Device | Active Comparator |
| |
| Sham eTNS Device | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigeminal Nerve Stimulation | Device | This intervention is expected to have an effect following a treatment period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADHD Symptoms | Examine the efficacy of external Trigeminal Nerve Stimulation (eTNS) in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5; range 0-54), where higher scores indicate worse symptoms. | Baseline to end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Responsiveness | Examine changes in social communication and related behaviors as measured by the Social Responsiveness Scale, Second Edition, Short Form (SRS-2-SF; range 0-48), where higher scores indicate worse impairment. | Baseline to end of treatment at 6 weeks |
| Change in Restricted and Repetitive Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Nancy Friend Pritzker Psychiatry Building | Recruiting | San Francisco | California | 94107 | United States |
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| Sham Trigeminal Nerve Stimulation | Device | This intervention is NOT expected to have an effect following a treatment period of 6 weeks. |
|
Examine changes in restricted and repetitive behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R; range 0-129), where higher scores indicate more severe repetitive behaviors. |
| Baseline to end of treatment at 6 weeks |
| Change in Sleep Quality | Examine changes in sleep quality as measured by the Children's Sleep Habits Questionnaire (CSHQ; range 33-99), where higher scores indicate poorer sleep quality. | Baseline to end of treatment at 6 weeks |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
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