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Recruiting NCT03827941

Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1 Hz Auricular transcutaneous electrical nerve stimulation, 20 Hz Auricular transcutaneous electrical nerve stimulation.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other 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.
  • Other 20 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.

Primary outcome measures

  • Change in Autism Treatment Evaluation Checklist (ATEC) [Time frame: Baseline and after 3-week treatment]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • MGB — Charlestown

Identifiers

NCT: NCT03827941 · 2017P000894

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗