Autism Spectrum Disorder Clinical Trial
Official title:
High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in Autism Spectrum Disorder (ASD)
NCT number | NCT03859336 |
Other study ID # | TENS_ASD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2019 |
Est. completion date | October 6, 2021 |
Verified date | December 2021 |
Source | Phoenix Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Spectrum Disorder (ASD). The specific aim is to determine the effect of TENS, delivered over 3 daily sessions, on anxiety and sleep quality in young adults with ASD, as compared to sham and baseline. The investigator will enroll up to 10 young adults, aged 10 to 25 years of age with confirmed ASD and measureable anxiety and sleep disturbance symptoms, and participation will last 3 weeks.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 6, 2021 |
Est. primary completion date | July 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - • 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 |
Country | Name | City | State |
---|---|---|---|
United States | Phoenix Children's Hospital | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Phoenix Children's Hospital |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in physiological response measure of heart rate variability in the time-domain as measured by the standard deviation of the normal-to-normal heart beat (SDNN) | The standard deviation of the normal-to-normal heart beat (SDNN) is the time-domain based measured of heart rate variability. It is measured by calculating the standard deviation of the heart beat-to-beat time interval, which is measured in milliseconds. Anxiety reduction will be demonstrated by a reduction in the SDNN value during a stressor in response to TEN treatment, as compared to baseline. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Primary | Change in physiological response measure of heart rate variability in the frequency-domain as measured by the power of the low frequency (LF) band | The low frequency (LF) component of heart rate variability (HRV) is the frequency band ranging from 0.04-0.15Hz of the waveform created by heart rate oscillations. Spectral power is calculated for this band in milliseconds squared. Anxiety reduction will be demonstrated by a reduction in the power value of the LF HRV component during a stressor in response to TEN treatment, as compared to baseline. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Primary | Change in physiological response measure of heart rate variability in the frequency-domain as measured by the power of the high frequency (HF) band | The high frequency (HF) component of heart rate variability (HRV) is the frequency band ranging from 0.15-0.4Hz of the waveform created by heart rate oscillations. Spectral power is calculated for this band in milliseconds squared. Anxiety reduction will be demonstrated by a reduction in the power value of the HF HRV component during a stressor in response to TEN treatment, as compared to baseline. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Primary | Change in physiological response measure of galvanic skin response (GSR) | Galvanic skin response (GSR) is an electrodermal conductance measurement that reflects the changes in sweat gland activity, which is measured in microsiemens (µS). Anxiety reduction will be analyzed through a suppression of GSR activity value during a stressor in response to TEN treatment, as compared to baseline data. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Secondary | Change in the Screen for Child Anxiety Related Disorders (SCARED) score | The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item self-reported inventory that measures anxiety in youth with ASD. Each item rates the severity of a symptom or behavior on a 3 point scale from 0 (Not true or Hardly Ever True) to 2 (Very True or Often True). A decrease in the total score of the 41 items, ranging from 0 to 82, will be used as a secondary measure to define a positive response. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Secondary | Change in the Parent Reported Anxiety Scale (PRAS) score | The Parent-rated Anxiety Scale for Autism Spectrum Disorder is a 25-item scale that measures anxiety in youth with ASD. Each item rates the severity of a behavior on a 4 point scale from 0 (None/not present) to 3 (Severe/Very frequent and a major problem). A decrease in the total score of the 25 items, ranging from 0 to 75, will be used as a secondary measure to define a positive response. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Secondary | Change in amylase and cortisol levels | Another secondary outcome measure for anxiety will be to quantify a-amylase and cortisol levels in the collected saliva samples, comparing post-treatment sample levels to pre-treatment within a visit. Successful anxiety reduction will be demonstrated by reduced levels of a-amylase and cortisol in the sample as compared to pre-TEN treatment levels. | Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5) | |
Secondary | Change in the Children's Sleep Habits Questionnaire (CSHQ) score | The Children's Sleep Habits Questionnaire (CSHQ) is a 39-item informant-reported questionnaire that measures sleep quality in children. Each item rates the frequency of a sleeping behavior on a 3 point scale from 1 (Never/Rarely, 0-1 nights per week) to 3(Usually, 5-7 nights pers week). The questionnaire also consists of questions asking whether certain behaviors are a problem with the options of a "yes" or "no" response. Improved sleep quality will be determined by a decrease in scores on the CSHQ subscales and the CSHQ combined total score, ranging from 31-93. |
Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5), Follow-Up (1 week following sham visit) |
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