Status:
COMPLETED
High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD
Lead Sponsor:
Phoenix Children's Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
10-25 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the feasibility of cervical TEN stimulation (TENS) delivered to the back of the neck to decrease anxiety and sleep issues in young adults with Autism Spec...
Detailed Description
Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder with life-long consequences that affects children during critical times in their development. ASD is associated with co-oc...
Eligibility Criteria
Inclusion
- Between the age of 10 - 25 years old
- IQ \> 80, to be evaluated during the screening visit using the Kaufman Brief Intelligence Test (KBIT)
- Self-reported complaints about anxiety and/or sleep issues
- Screen for Child Anxiety Related Disorders (SCARED) - Parent Form, score \>= 25
- Able to follow directions in English
Exclusion
- • IQ ≤ 80, to be evaluated during the screening visit using the KBIT
- SCARED - Parent Form, Score \< 25
- Has a medical implant (such as a pacemaker, cochlear implant, brain stimulation device, spinal stimulator)
- History of significant face/head injury including cranial or facial metal plate or screw implants
- Pregnant
- History of migraines or frequent headaches (more than once a week)
- Started taking anti-anxiety medications less than 3 months prior to study participation or has not been taking anti-anxiety medications consistently for at least 3 months prior to study participation
- Fainting (vaso-vagal syncope or neurocardiogenic syncope)
- Diagnosis of Raynaud's disease
- Tempromandibular joint (TMJ) disorder or other facial neuropathy
- Poor vision or hearing that is uncorrectable
- Seizures in the last 2 years
- Evidence of skin disease or skin abnormalities affecting the neck or upper back
- Upper extremity contractures
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03859336
Start Date
May 21 2019
End Date
October 6 2021
Last Update
December 20 2021
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016