Recruiting

Transcutaneous Electrical Nerve Stimulation

Sponsor:

Massachusetts General Hospital

Code:

NCT03827941

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

1 Hz Auricular transcutaneous electrical nerve stimulation

20 Hz Auricular transcutaneous electrical nerve stimulation

Study Details

Brief summary:

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

Conditions

Autism Spectrum Disorder

Study ID

NCT03827941

Start date

Nov 1, 2022

Status verified date

Jul, 2026

Completion date

Sep 28, 2027

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in Autism Treatment Evaluation Checklist (ATEC) [ Time Frame: Baseline and after 3-week treatment ]

Central Contacts and Locations

Central contacts

Sierra Hodges

6177267893sahodges@mgb.org

Locations

MGB

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Sierra

sahodges@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-17.