Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: 20 Hz Auricular transcutaneous electrical nerve stimulation; Other: 1 Hz Auricular transcutaneous electrical nerve stimulation

• Registration Number: NCT03827941
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.

Detailed Description

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 Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09
• Study Start: 2022-10-01
• Primary Completion: 2024-01-28
• Study Completion: 2024-01-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Autism diagnosed based on DSM-V classification criteria
2. 18-60 year old high functioning adult autism patients (e.g. Asperger's, IQ equal or greater than 80)
3. Subjects who do not show aggressive behaviors based on neuro/psychiatric evaluations as determined by a licensed study physician.

Exclusion Criteria

1. A history of chronic serious infection, any current infection, any type of cancer or autoimmune disease or other severe diseases;
2. Subjects taking any medications that confound the study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 Hz group	20 Hz Auricular transcutaneous electrical nerve stimulation	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.
1 Hz group	1 Hz Auricular transcutaneous electrical nerve stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in Autism Treatment Evaluation Checklist (ATEC)	Baseline and after 3-week treatment	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.

Secondary Outcome Measures

Name	Time	Method
Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)	Baseline and after 3-week treatment	6 minutes PPG data will be collected
Change in Aberrant Behavior Checklist (ABC)	Baseline and after 3-week treatment	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.
Change in Sleep Quality Assessment (PSQI)	Baseline and after 3-week treatment	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.
EEG (optional)	Baseline and after 3-week treatment	Resting state EEG (filter 1-50 Hz) will be collected
Salivary oxytocin quantification (optional)	Baseline and after 3-week treatment	A total of 4-mL of unstimulated saliva will be collected
Change in Clinical Global Impression-Improvement (CGI-I)	Baseline and after 3-week treatment	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.
Change in PROMIS Sleep Disturbance Short Form	Baseline and after 3-week treatment	This questionnaire is used to assess the pure domain of sleep disturbance in adults.
PROMIS-29	Baseline and after 3-week treatment	The PROMIS-29 assesses pain intensity, physical function, depression, anxiety, fatigue, sleep disturbance, interference, and social role and activity in the past 7 days
Pulse oximetry measurements (optional)	Baseline and after 3-week treatment	SpCO will be measured at different time points
Change in Penn State Worry Questionnaire	Baseline and after 3-week treatment	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".
Quantification of species-level L. reuteri abundance in human stool samples (optional)	Baseline and after 3-week treatment	Stool samples will be collected at home following our provided instructions.
ECG (optional)	Baseline and after 3-week treatment	6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis