Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03827941
• Other study ID #: 2017P000894
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 28, 2024

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: Amy Ursitti
• Phone: 6177267893
• Email: aursitti[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• 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.
• 20 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Baseline and after 3-week treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EEG (optional)	Resting state EEG (filter 1-50 Hz) will be collected	Baseline and after 3-week treatment
Secondary	Salivary oxytocin quantification (optional)	A total of 4-mL of unstimulated saliva will be collected	Baseline and after 3-week treatment
Secondary	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
Secondary	Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)	6 minutes PPG data will be collected	Baseline and after 3-week treatment
Secondary	ECG (optional)	6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis	Baseline and after 3-week treatment
Secondary	Pulse oximetry measurements (optional)	SpCO will be measured at different time points	Baseline and after 3-week treatment