Autism Spectrum DisorderNCT03827941
Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
A study testing 1 Hz Auricular transcutaneous electrical nerve stimulation and 20 Hz Auricular transcutaneous electrical nerve stimulation in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- 1 Hz Auricular transcutaneous electrical nerve stimulation and 20 Hz Auricular transcutaneous electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 28 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGB
Charlestown, Massachusetts, 02129
Sierra, sahodges@mgb.org
Hodges
About this study
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 1 Hz Auricular transcutaneous electrical nerve stimulation, 20 Hz Auricular transcutaneous electrical nerve stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Hz Auricular transcutaneous electrical nerve stimulationOther
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.
20 Hz Auricular transcutaneous electrical nerve stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Hz group | Active comparator | 1 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. Receives: Other: 1 Hz Auricular transcutaneous electrical nerve stimulation |
| 20 Hz group | Active comparator | 20 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 20 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. Receives: Other: 20 Hz Auricular transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autism Treatment Evaluation Checklist (ATEC)
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.
Measured: Baseline and after 3-week treatment
Secondary outcomes (12)
Change in Aberrant Behavior Checklist (ABC)
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.
Measured: Baseline and after 3-week treatment
Change in Clinical Global Impression-Improvement (CGI-I)
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.
Measured: Baseline and after 3-week treatment
Change in PROMIS Sleep Disturbance Short Form
This questionnaire is used to assess the pure domain of sleep disturbance in adults.
Measured: Baseline and after 3-week treatment
Change in Penn State Worry Questionnaire
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".
Measured: Baseline and after 3-week treatment
Change in Sleep Quality Assessment (PSQI)
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.
Measured: Baseline and after 3-week treatment
PROMIS-29
The PROMIS-29 assesses pain intensity, physical function, depression, anxiety, fatigue, sleep disturbance, interference, and social role and activity in the past 7 days
Measured: Baseline and after 3-week treatment
EEG (optional)
Resting state EEG (filter 1-50 Hz) will be collected
Measured: Baseline and after 3-week treatment
Salivary oxytocin quantification (optional)
A total of 4-mL of unstimulated saliva will be collected
Measured: Baseline and after 3-week treatment
Quantification of species-level L. reuteri abundance in human stool samples (optional)
Stool samples will be collected at home following our provided instructions.
Measured: Baseline and after 3-week treatment
Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
6 minutes PPG data will be collected
Measured: Baseline and after 3-week treatment
ECG (optional)
6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
Measured: Baseline and after 3-week treatment
Pulse oximetry measurements (optional)
SpCO will be measured at different time points
Measured: Baseline and after 3-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Nov 2022
- Primary completion28 Sep 2027 (estimated)
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
- Investigators
- Jian Kong, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827941
- Sponsor's protocol ID
- 2017P000894
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2019
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
- ClinicalTrials.gov ID
- NCT03827941
- Acronym / sponsor ID
- 2017P000894
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 28 Sep 2027 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Hz group | Active comparator | Other: 1 Hz Auricular transcutaneous electrical nerve stimulation1 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. |
| 20 Hz group | Active comparator | Other: 20 Hz Auricular transcutaneous electrical nerve stimulation20 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 20 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Hz Auricular transcutaneous electrical nerve stimulationHigh-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. | Other | 1 Hz group |
| 20 Hz Auricular transcutaneous electrical nerve stimulationHigh-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. | Other | 20 Hz group |
Primary outcome
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.
12 secondary outcomes
Change in Aberrant Behavior Checklist (ABC)
Time frame: Baseline and after 3-week treatment
Change in Clinical Global Impression-Improvement (CGI-I)
Time frame: Baseline and after 3-week treatment
Change in PROMIS Sleep Disturbance Short Form
Time frame: Baseline and after 3-week treatment
Change in Penn State Worry Questionnaire
Time frame: Baseline and after 3-week treatment
Change in Sleep Quality Assessment (PSQI)
Time frame: Baseline and after 3-week treatment
PROMIS-29
Time frame: Baseline and after 3-week treatment
EEG (optional)
Time frame: Baseline and after 3-week treatment
Salivary oxytocin quantification (optional)
Time frame: Baseline and after 3-week treatment
Quantification of species-level L. reuteri abundance in human stool samples (optional)
Time frame: Baseline and after 3-week treatment
Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
Time frame: Baseline and after 3-week treatment
ECG (optional)
Time frame: Baseline and after 3-week treatment
Pulse oximetry measurements (optional)
Time frame: Baseline and after 3-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Kong principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Hz Auricular transcutaneous electrical nerve stimulation and 20 Hz Auricular transcutaneous electrical nerve stimulation in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sierra Hodges (6177267893, sahodges@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Autism Treatment Evaluation Checklist (ATEC) (time frame: Baseline and after 3-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.