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Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1 Hz Auricular transcutaneous electrical nerve stimulation
20 Hz Auricular transcutaneous electrical nerve stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1 Hz group

    20 Hz group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Change in PROMIS Sleep Disturbance Short Form
    This questionnaire is used to assess the pure domain of sleep disturbance in adults.
    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".
    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.
    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
    EEG (optional)
    Resting state EEG (filter 1-50 Hz) will be collected
    Salivary oxytocin quantification (optional)
    A total of 4-mL of unstimulated saliva will be collected
    Quantification of species-level L. reuteri abundance in human stool samples (optional)
    Stool samples will be collected at home following our provided instructions.
    Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
    6 minutes PPG data will be collected
    ECG (optional)
    6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
    Pulse oximetry measurements (optional)
    SpCO will be measured at different time points

    Full Information

    First Posted
    January 28, 2019
    Last Updated
    September 6, 2022
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03827941
    Brief Title
    Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
    Official Title
    Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    January 28, 2024 (Anticipated)
    Study Completion Date
    January 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Hz group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    20 Hz group
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    1 Hz Auricular transcutaneous electrical nerve stimulation
    Intervention Description
    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 Type
    Other
    Intervention Name(s)
    20 Hz Auricular transcutaneous electrical nerve stimulation
    Intervention Description
    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 Measure Information:
    Title
    Change in Autism Treatment Evaluation Checklist (ATEC)
    Description
    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.
    Time Frame
    Baseline and after 3-week treatment
    Secondary Outcome Measure Information:
    Title
    Change in Aberrant Behavior Checklist (ABC)
    Description
    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.
    Time Frame
    Baseline and after 3-week treatment
    Title
    Change in Clinical Global Impression-Improvement (CGI-I)
    Description
    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.
    Time Frame
    Baseline and after 3-week treatment
    Title
    Change in PROMIS Sleep Disturbance Short Form
    Description
    This questionnaire is used to assess the pure domain of sleep disturbance in adults.
    Time Frame
    Baseline and after 3-week treatment
    Title
    Change in Penn State Worry Questionnaire
    Description
    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".
    Time Frame
    Baseline and after 3-week treatment
    Title
    Change in Sleep Quality Assessment (PSQI)
    Description
    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.
    Time Frame
    Baseline and after 3-week treatment
    Title
    PROMIS-29
    Description
    The PROMIS-29 assesses pain intensity, physical function, depression, anxiety, fatigue, sleep disturbance, interference, and social role and activity in the past 7 days
    Time Frame
    Baseline and after 3-week treatment
    Title
    EEG (optional)
    Description
    Resting state EEG (filter 1-50 Hz) will be collected
    Time Frame
    Baseline and after 3-week treatment
    Title
    Salivary oxytocin quantification (optional)
    Description
    A total of 4-mL of unstimulated saliva will be collected
    Time Frame
    Baseline and after 3-week treatment
    Title
    Quantification of species-level L. reuteri abundance in human stool samples (optional)
    Description
    Stool samples will be collected at home following our provided instructions.
    Time Frame
    Baseline and after 3-week treatment
    Title
    Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)
    Description
    6 minutes PPG data will be collected
    Time Frame
    Baseline and after 3-week treatment
    Title
    ECG (optional)
    Description
    6 minutes raw ECG data will be collected for Heart rate variability (HRV) analysis
    Time Frame
    Baseline and after 3-week treatment
    Title
    Pulse oximetry measurements (optional)
    Description
    SpCO will be measured at different time points
    Time Frame
    Baseline and after 3-week treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Ursitti
    Phone
    6177267893
    Email
    aursitti@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jian Kong
    Organizational Affiliation
    MGH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

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