Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

September 6, 2022 updated by: Jian Kong, Massachusetts General Hospital
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Hz group
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.
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.
Active Comparator: 20 Hz group
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Autism Treatment Evaluation Checklist (ATEC)
Time Frame: 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.
Baseline and after 3-week treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Aberrant Behavior Checklist (ABC)
Time Frame: 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.
Baseline and after 3-week treatment
Change in Clinical Global Impression-Improvement (CGI-I)
Time Frame: 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.
Baseline and after 3-week treatment
Change in PROMIS Sleep Disturbance Short Form
Time Frame: Baseline and after 3-week treatment
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
Time Frame: 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".
Baseline and after 3-week treatment
Change in Sleep Quality Assessment (PSQI)
Time Frame: 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.
Baseline and after 3-week treatment
PROMIS-29
Time Frame: 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
Baseline and after 3-week treatment
EEG (optional)
Time Frame: Baseline and after 3-week treatment
Resting state EEG (filter 1-50 Hz) will be collected
Baseline and after 3-week treatment
Salivary oxytocin quantification (optional)
Time Frame: Baseline and after 3-week treatment
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)
Time Frame: Baseline and after 3-week treatment
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)
Time Frame: Baseline and after 3-week treatment
6 minutes PPG data will be collected
Baseline and after 3-week treatment
ECG (optional)
Time Frame: Baseline and after 3-week treatment
6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
Baseline and after 3-week treatment
Pulse oximetry measurements (optional)
Time Frame: Baseline and after 3-week treatment
SpCO will be measured at different time points
Baseline and after 3-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

January 28, 2024

Study Completion (Anticipated)

January 28, 2024

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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