NCT03827941NARecruiting
Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Massachusetts General Hospital
Start Date
11/1/2022
Completion Date
9/28/2027
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.
Eligibility Criteria
Age Range: 18 years to 60 years
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
Interventions
OTHER
1 Hz Auricular transcutaneous electrical nerve stimulation
OTHER
20 Hz Auricular transcutaneous electrical nerve stimulation
Conditions
Autism Spectrum Disorder
Locations
MGB
Charlestown, Massachusetts 02129
United States