Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
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
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2024
CompletedSeptember 9, 2022
September 1, 2022
1.3 years
January 28, 2019
September 6, 2022
Conditions
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 COMPARATOR1 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 group
ACTIVE COMPARATOR20 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.
Interventions
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Kong
MGH
Central Study Contacts
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
October 1, 2022
Primary Completion
January 28, 2024
Study Completion
January 28, 2024
Last Updated
September 9, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share