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Trial record 20 of 330 for:    autism | Recruiting, Not yet recruiting, Available Studies

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 : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Brief Summary:
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: 1 Hz Auricular transcutaneous electrical nerve stimulation Other: 20 Hz Auricular transcutaneous electrical nerve stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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 :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827941


Contacts
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Contact: Joel Park 6177267893 jpark51@partners.org
Contact: Madelyn Koh mkoh@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jian Kong MGH

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Responsible Party: Jian Kong, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03827941     History of Changes
Other Study ID Numbers: 2017P000894
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders