Autism Spectrum Disorder
Conditions
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.
Interventions
OTHER1 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.
OTHER20 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Autism Treatment Evaluation Checklist (ATEC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Aberrant Behavior Checklist (ABC) | Baseline and after 3-week treatment | The factors of the ABC have been labeled as follows: (I) Irritability, Agitation, Crying; (II) Lethargy, Social Withdrawal; (III) Stereotypic Behavior; (IV) Hyperactivity, Noncompliance; and (V) Inappropriate Speech. |
| Change in Clinical Global Impression-Improvement (CGI-I) | Baseline and after 3-week treatment | Overall improvement in autism will be assessed using the Clinical Global Impression-Improvement (CGI-I) scale, a 7-point scale from 1 = very much improved to 7 = very much worse. |
| Change in PROMIS Sleep Disturbance Short Form | Baseline and after 3-week treatment | This questionnaire is used to assess the pure domain of sleep disturbance in adults. |
| Change in Penn State Worry Questionnaire | Baseline and after 3-week treatment | This is the standard assessment of worry and consists of 16 questions rated from 1 to 5 from "Not typical of me" to "Very typical of me". |
| Change in Sleep Quality Assessment (PSQI) | Baseline and after 3-week treatment | The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last week. |
| PROMIS-29 | Baseline and after 3-week treatment | The PROMIS-29 assesses pain intensity, physical function, depression, anxiety, fatigue, sleep disturbance, interference, and social role and activity in the past 7 days |
| EEG (optional) | Baseline and after 3-week treatment | Resting state EEG (filter 1-50 Hz) will be collected |
| Salivary oxytocin quantification (optional) | Baseline and after 3-week treatment | A total of 4-mL of unstimulated saliva will be collected |
| Quantification of species-level L. reuteri abundance in human stool samples (optional) | Baseline and after 3-week treatment | Stool samples will be collected at home following our provided instructions. |
| Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional) | Baseline and after 3-week treatment | 6 minutes PPG data will be collected |
| ECG (optional) | Baseline and after 3-week treatment | 6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis |
| Pulse oximetry measurements (optional) | Baseline and after 3-week treatment | SpCO will be measured at different time points |
Countries
United States
Contacts
CONTACTSierra Hodges
PRINCIPAL_INVESTIGATORJian Kong
MGH
Outcome results
None listed