MGB
Charlestown, Massachusetts, 02129, United States
Location status: Recruiting
Recruiting
NCT Number: NCT03827941
Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
1 Hz Auricular transcutaneous electrical nerve stimulation
OtherHigh-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.
20 Hz Auricular transcutaneous electrical nerve stimulation
OtherHigh-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.
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
-
Change in Aberrant Behavior Checklist (ABC)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline and after 3-week treatment
Resting state EEG (filter 1-50 Hz) will be collected
-
Salivary oxytocin quantification (optional)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and after 3-week treatment
6 minutes PPG data will be collected
-
ECG (optional)
Time frame: Baseline and after 3-week treatment
6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
-
Pulse oximetry measurements (optional)
Time frame: Baseline and after 3-week treatment
SpCO will be measured at different time points
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Massachusetts General Hospital
Other
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 4, 2019
- Registry last updated
- Jul 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
Developing Brain, Impulsivity and Compulsivity
NCT04631042
Anxiety Disorders, Attention Deficit Disorder with Hyperactivity
Bethesda, Maryland, United States
View Trial Details
Recruiting
Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids
NCT07727018
Autism Spectrum Disorder, Avoidant Restrictive Food Intake Disorder
Tijuana, Estado de Baja California, Mexico
View Trial Details
Recruiting
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
NCT06081348
22Q11 Deletion, 22q11 Deletion Syndrome
Calgary, Alberta, Canada
View Trial Details
Recruiting
Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder
NCT07722949
Anxiety, Anxiety Disorders
Faisalābad, Punjab Province, Pakistan
View Trial Details