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In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.
In this study, investigators will examine the treatment effect of transcutaneous electrical nerve stimulation at auricular area with vagus nerve distribution on high-functioning individuals with autism. Specifically, investigators will choose two ear acupoints: heart and shenmen. Participants will be randomized to either 1 Hz or 20 Hz tVNS group (up to 5 times per week) for three weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Hz group | Active Comparator | 1 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. |
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| 20 Hz group | Active Comparator | 20 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 20 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Hz Auricular transcutaneous electrical nerve stimulation | Other | High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Autism Treatment Evaluation Checklist (ATEC) | ATEC will be reported by investigator in a total and for each of the 4 subscales as follows: (1) speech/language/communication subscale; (2) social subscale; (3) sensory and cognitive awareness subscale; and (4) health / physical / behavior problem subscale. The total score ranges from 0 to 179; a higher score indicated worsening while a lower score indicated improvement. | Baseline and after 3-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aberrant Behavior Checklist (ABC) | The factors of the ABC have been labeled as follows: (I) Irritability, Agitation, Crying; (II) Lethargy, Social Withdrawal; (III) Stereotypic Behavior; (IV) Hyperactivity, Noncompliance; and (V) Inappropriate Speech. | Baseline and after 3-week treatment |
| Change in Clinical Global Impression-Improvement (CGI-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Ursitti | Contact | 6177267893 | aursitti@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jian Kong | MGH | Principal Investigator |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 20 Hz Auricular transcutaneous electrical nerve stimulation | Other | High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. |
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Overall improvement in autism will be assessed using the Clinical Global Impression-Improvement (CGI-I) scale, a 7-point scale from 1 = very much improved to 7 = very much worse. |
| Baseline and after 3-week treatment |
| Change in PROMIS Sleep Disturbance Short Form | This questionnaire is used to assess the pure domain of sleep disturbance in adults. | Baseline and after 3-week treatment |
| Change in Penn State Worry Questionnaire | This is the standard assessment of worry and consists of 16 questions rated from 1 to 5 from "Not typical of me" to "Very typical of me". | Baseline and after 3-week treatment |
| Change in Sleep Quality Assessment (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last week. | Baseline and after 3-week treatment |
| PROMIS-29 | The PROMIS-29 assesses pain intensity, physical function, depression, anxiety, fatigue, sleep disturbance, interference, and social role and activity in the past 7 days | Baseline and after 3-week treatment |
| EEG (optional) | Resting state EEG (filter 1-50 Hz) will be collected | Baseline and after 3-week treatment |
| Salivary oxytocin quantification (optional) | A total of 4-mL of unstimulated saliva will be collected | Baseline and after 3-week treatment |
| Quantification of species-level L. reuteri abundance in human stool samples (optional) | Stool samples will be collected at home following our provided instructions. | Baseline and after 3-week treatment |
| Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional) | 6 minutes PPG data will be collected | Baseline and after 3-week treatment |
| ECG (optional) | 6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis | Baseline and after 3-week treatment |
| Pulse oximetry measurements (optional) | SpCO will be measured at different time points | Baseline and after 3-week treatment |