NCT03827941

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Nov 2022Sep 2027

First Submitted

Initial submission to the registry

January 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

4.9 years

First QC Date

January 28, 2019

Last Update Submit

July 16, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after 3-week treatment

Secondary Outcomes (12)

  • Change in Aberrant Behavior Checklist (ABC)

    Baseline and after 3-week treatment

  • Change in Clinical Global Impression-Improvement (CGI-I)

    Baseline and after 3-week treatment

  • Change in PROMIS Sleep Disturbance Short Form

    Baseline and after 3-week treatment

  • Change in Penn State Worry Questionnaire

    Baseline and after 3-week treatment

  • Change in Sleep Quality Assessment (PSQI)

    Baseline and after 3-week treatment

  • +7 more secondary outcomes

Study Arms (2)

1 Hz group

ACTIVE COMPARATOR

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

20 Hz group

ACTIVE COMPARATOR

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

Interventions

1 Hz Auricular transcutaneous electrical nerve stimulationOTHER

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.

1 Hz group
20 Hz Auricular transcutaneous electrical nerve stimulationOTHER

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 group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Autism diagnosed based on DSM-V classification criteria
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGB

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jian Kong

    MGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sierra Hodges

CONTACT

6177267893sahodges@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 4, 2019

Study Start

November 1, 2022

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

September 28, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)