Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Mass General Brigham

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Other: 1 Hz Auricular transcutaneous electrical nerve stimulation; Other: 20 Hz Auricular transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03827941

2017P000894

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

1 Hz group

Active Comparator group

Description:

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.

Treatment:

Other: 1 Hz Auricular transcutaneous electrical nerve stimulation

20 Hz group

Active Comparator group

Description:

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.

Treatment:

Other: 20 Hz Auricular transcutaneous electrical nerve stimulation