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Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

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ClinicalTrials.gov Identifier: NCT03827941
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date May 12, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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 month.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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.
  • 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".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Official Title  ICMJE Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1 Hz group
    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.
    Intervention: Other: 1 Hz Auricular transcutaneous electrical nerve stimulation
  • Active Comparator: 20 Hz group
    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.
    Intervention: Other: 20 Hz Auricular transcutaneous electrical nerve stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 28, 2021
Estimated Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joel Park 6177267893 jpark51@partners.org
Contact: Madelyn Koh mkoh@mgh.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827941
Other Study ID Numbers  ICMJE 2017P000894
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian Kong, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Kong MGH
PRS Account Massachusetts General Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP