High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in physiological response measure of heart rate variability in the frequency-domain as measured by the power of the low frequency (LF) band
研究概览
简要总结
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.
详细描述
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-occurring problems such as anxiety and sleep disturbances. New approaches to managing stress, anxiety, and sleep quality would greatly enhance the quality of life and activities of daily living for children with ASD as they transition to adulthood and age out of services. Based on strong evidence from typically developing individuals, the technology for transdermal electrical neuromodulation (TEN) of the cranial nerves has shown to be a safe, effective, comfortable, and non-pharmacological therapy to modulate the central nervous system decreasing anxiety and enhancing sleep quality to improve the quality of life for people with ASD.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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
- •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
结局指标
主要结局
Change in physiological response measure of heart rate variability in the frequency-domain as measured by the power of the low frequency (LF) band
时间窗: Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5)
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.
Change in physiological response measure of heart rate variability in the frequency-domain as measured by the power of the high frequency (HF) band
时间窗: Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5)
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.
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)
时间窗: Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5)
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.
Change in physiological response measure of galvanic skin response (GSR)
时间窗: Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5)
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.
次要结局
- Change in the Screen for Child Anxiety Related Disorders (SCARED) score(Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5))
- Change in the Parent Reported Anxiety Scale (PRAS) score(Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5))
- Change in amylase and cortisol levels(Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5))
- Change in the Children's Sleep Habits Questionnaire (CSHQ) score(Baseline Visit (Day 1), Treatment Visits (Days 2, 3, and 4), Sham Visit (Day 5), Follow-Up (1 week following sham visit))
研究者
Richard Frye, MD, PhD
Chief of Neurodevelopmental Disorders at Barrow Neurological Institute
Phoenix Children's Hospital