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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
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.
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.
Time frame: Baseline and after 3-week treatment
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.
Time frame: Baseline and after 3-week treatment
Change in Clinical Global Impression-Improvement (CGI-I)
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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
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Time frame: 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
Time frame: Baseline and after 3-week treatment
EEG (optional)
Resting state EEG (filter 1-50 Hz) will be collected
Time frame: Baseline and after 3-week treatment
Salivary oxytocin quantification (optional)
A total of 4-mL of unstimulated saliva will be collected
Time frame: 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.
Time frame: Baseline and after 3-week treatment
Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
6 minutes PPG data will be collected
Time frame: Baseline and after 3-week treatment
ECG (optional)
6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
Time frame: Baseline and after 3-week treatment
Pulse oximetry measurements (optional)
SpCO will be measured at different time points
Time frame: Baseline and after 3-week treatment