Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 40
- Primary Endpoint
- Change in Autism Treatment Evaluation Checklist (ATEC)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jian Kong
Associate Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Autism diagnosed based on DSM-V classification criteria
- •18-60 year old high functioning adult autism patients (e.g. Asperger's, IQ equal or greater than 80)
- •Subjects who do not show aggressive behaviors based on neuro/psychiatric evaluations as determined by a licensed study physician.
Exclusion Criteria
- •A history of chronic serious infection, any current infection, any type of cancer or autoimmune disease or other severe diseases;
- •Subjects taking any medications that confound the study results
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)(Baseline and after 3-week treatment)
- Change in Aberrant Behavior Checklist (ABC)(Baseline and after 3-week treatment)
- Change in Sleep Quality Assessment (PSQI)(Baseline and after 3-week treatment)
- EEG (optional)(Baseline and after 3-week treatment)
- Salivary oxytocin quantification (optional)(Baseline and after 3-week treatment)
- Change in Clinical Global Impression-Improvement (CGI-I)(Baseline and after 3-week treatment)
- Change in PROMIS Sleep Disturbance Short Form(Baseline and after 3-week treatment)
- PROMIS-29(Baseline and after 3-week treatment)
- Pulse oximetry measurements (optional)(Baseline and after 3-week treatment)
- Change in Penn State Worry Questionnaire(Baseline and after 3-week treatment)
- Quantification of species-level L. reuteri abundance in human stool samples (optional)(Baseline and after 3-week treatment)
- ECG (optional)(Baseline and after 3-week treatment)