Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03827941
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 1 Hz Auricular transcutaneous electrical nerve stimulation — OTHER
    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 — OTHER
    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 Details

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

Key Dates

First listed
Feb 4, 2019
Start date
Nov 1, 2022
Status verified
Jul 2026
Primary completion
Sep 28, 2027
Completion
Sep 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Autism Treatment Evaluation Checklist (ATEC) [ Time Frame: Baseline and after 3-week treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGBCharlestownMassachusetts02129
Hodges

Find similar trials in Charlestown, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
MGB· Charlestown, MA

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