Clinical trial NCT03827941: Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Official title: Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Change in Autism Treatment Evaluation Checklist (ATEC)
timeFrame: Baseline and after 3-week treatment
Secondary outcomes:
measure: Change in Aberrant Behavior Checklist (ABC)
timeFrame: Baseline and after 3-week treatment
measure: Change in Clinical Global Impression-Improvement (CGI-I)
timeFrame: Baseline and after 3-week treatment
measure: Change in PROMIS Sleep Disturbance Short Form
timeFrame: Baseline and after 3-week treatment
measure: Change in Penn State Worry Questionnaire
timeFrame: Baseline and after 3-week treatment
measure: Change in Sleep Quality Assessment (PSQI)
timeFrame: Baseline and after 3-week treatment
measure: PROMIS-29
timeFrame: Baseline and after 3-week treatment
measure: EEG (optional)
timeFrame: Baseline and after 3-week treatment
measure: Salivary oxytocin quantification (optional)
timeFrame: Baseline and after 3-week treatment
measure: Quantification of species-level L. reuteri abundance in human stool samples (optional)
timeFrame: Baseline and after 3-week treatment
measure: Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
timeFrame: Baseline and after 3-week treatment
measure: ECG (optional)
timeFrame: Baseline and after 3-week treatment
measure: Pulse oximetry measurements (optional)
timeFrame: Baseline and after 3-week treatment
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Jian Kong
role: PRINCIPAL_INVESTIGATOR
References: