High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD
NCT ID: NCT03859336
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2019-05-21
2021-10-06
Brief Summary
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Detailed Description
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The therapy applies tuned, high-frequency TEN to the back of the neck which activates the brainstem modulating noradrenergic signaling shown to decrease anxiety in healthy adults. The low-amplitude of the stimulation means that it is painless and comfortable. Furthermore, the technology is being evaluated for improving sleep quality. The mechanism of these effects are well established in the neurophysiology literature, but modulating these brainstem areas is only now possible non-invasively with the technology. Participants entered into the trial wil have anxiety and sleep issues that are known to be associated with ASD. The investigators hypothesize that cervical TEN will decrease anxiety and improve sleep quality in a population with high-functioning ASD who are transitioning into adulthood.
The investigators will study 10 young adults, between the ages of 10 years to 25 years, with confirmed ASD and anxiety and sleep quality issues. All participants will be enrolled in the study for approximately 2 weeks. During the first week, participants will undergo 5 consecutive days of stimulation. On Visit 1, all participants will receive sham stimulation, which will be used to exclude placebo responders and those who cannot tolerate study procedures, and determine the maximum stimulation threshold for eligible participants. Additionally, the visit will serve as the baseline day to collect measures of anxiety. The primary physiological anxiety measures include galvanic skin response (GSR) and heart rate variability (HRV). Secondary measures will include data from behavioral surveys, and cortisol and amylase analyses from passive drool samples. Participants will report baseline sleep habits in the form of a questionnaire.
If all eligibility criteria are met, participants will return for 3 consecutive days of open label TEN stimulation treatment. Anxiety measures will be collected at each visit. On the fifth consecutive day, participants will once again receive sham stimulation in order to determine the impact of the open label treatment. Participation will conclude with a one day phone follow-up visit one week from the last treatment day. Caregivers will report participant sleep quality and any adverse effects or changes.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transdermal Neuromodulation Stimulation
Day 1 of Transdermal Neuromodulation Stimulation (TENS) is a one-day sham stimulation, consisting of: 30 seconds of sensation in which amplitude is increased up to the threshold of salient sensation, followed by 19 minutes of no stimulation (device is turned off), followed by 30 more seconds of salient stimulation. Day 1 is used to exclude those who cannot tolerate study procedures and placebo responders; it will also serve as baseline for anxiety measures. TENS treatment begins one day after sham, and lasts 3 days with 20 minutes of stimulation per day. One day following open label treatment all participants will once again receive sham stimulation following the same procedures utilized at Day 1.
Treatment amplitude is adjusted for each participant, in which the stimulation will be administered just below the participant's sensation threshold. Amplitude from the TENS device does not exceed 20mA. Frequency will be at 300hz.
Transdermal Neuromodulation Stimulation
The TEN device administers a tuned high frequency electrical stimulation delivered to the cervical plexus (C2-C4) on the back of the neck for 20 minutes. This stimulation will activate common trigeminovagal pathways modulating noradrenergic signaling to attenuate sympathetic activity. This stimulation can subsequently regulate the activity of several deep-brain nuclei within the ascending reticular activating system (RAS). Nuclei in the RAS regulate powerful neuromodulators like norepinephrine (NE), acetylcholine (ACh), and serotonin (5-HT). The investigators will examine whether this modulation from TENS will decrease anxiety and improve sleep quality in the study participants.
Interventions
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Transdermal Neuromodulation Stimulation
The TEN device administers a tuned high frequency electrical stimulation delivered to the cervical plexus (C2-C4) on the back of the neck for 20 minutes. This stimulation will activate common trigeminovagal pathways modulating noradrenergic signaling to attenuate sympathetic activity. This stimulation can subsequently regulate the activity of several deep-brain nuclei within the ascending reticular activating system (RAS). Nuclei in the RAS regulate powerful neuromodulators like norepinephrine (NE), acetylcholine (ACh), and serotonin (5-HT). The investigators will examine whether this modulation from TENS will decrease anxiety and improve sleep quality in the study participants.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
10 Years
25 Years
ALL
No
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Richard Frye, MD, PhD
Chief of Neurodevelopmental Disorders at Barrow Neurological Institute
Principal Investigators
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Richard E Frye, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Children's Hospital
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Countries
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References
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Tyler WJ, Boasso AM, Mortimore HM, Silva RS, Charlesworth JD, Marlin MA, Aebersold K, Aven L, Wetmore DZ, Pal SK. Transdermal neuromodulation of noradrenergic activity suppresses psychophysiological and biochemical stress responses in humans. Sci Rep. 2015 Sep 10;5:13865. doi: 10.1038/srep13865.
Boasso AM, Mortimore H, Silva R, Aven L, Tyler, WJ. Transdermal electrical neuromodulation of the trigeminal sensory nuclear complex improves sleep quality and mood. BioRxiv. 2016 Jan 1. doi: 10.1101/043901
Carter ME, Yizhar O, Chikahisa S, Nguyen H, Adamantidis A, Nishino S, Deisseroth K, de Lecea L. Tuning arousal with optogenetic modulation of locus coeruleus neurons. Nat Neurosci. 2010 Dec;13(12):1526-33. doi: 10.1038/nn.2682. Epub 2010 Oct 31.
van Steensel FJA, Heeman EJ. Anxiety Levels in Children with Autism Spectrum Disorder: A Meta-Analysis. J Child Fam Stud. 2017;26(7):1753-1767. doi: 10.1007/s10826-017-0687-7. Epub 2017 Mar 20.
White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.
Other Identifiers
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TENS_ASD
Identifier Type: -
Identifier Source: org_study_id