Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Aberrant Behavior Checklist-Community (ABC-C)
研究概览
简要总结
The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are:
- Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials.
- Examine the effects of VNS on a broad range of symptoms.
Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.
详细描述
Intellectual and developmental disabilities (IDD) cover a wide variety of disorders. Although we know the causes of some of the disorders and some of them could even be prevented (e.g., lead exposure), most causes remain unknown. Without having a clear understanding of the causes, prevention is very difficult to achieve. Previous studies have shown abnormal autonomic nervous system (ANS) regulations in young children with autism spectrum disorder (ASD) and these abnormalities are also observed during sleep. ANS is the part of the nervous system that controls the unconscious bodily functions, such as breathing, heart beating, and digestion.
The vagus nerve strongly influences these autonomic functions including digestion, breathing, heart rate variability, and metabolic function and central nervous system (CNS) activity that affect mood, pain, stress management, sleep, and even memory and cognitive functions. The vagal influence over neurotransmitter release has been implicated in the regulation of inflammation and immune cell activity.
Here, we are using a non-invasive vagus nerve stimulator to monitor changes in cognitive function and other symptoms in people with IDD, both with and without ASD. The device is FDA-approved for migraine and cluster headaches in people 12 years and older. VNS activates the vagus nerve with mild electrical stimulation through the skin.
Rather than embarking on a rigorously designed study, we will conduct a series of single-subject studies that reflects each participant's symptoms. We will select the most appropriate dependent variables based on each person's symptom presentation.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults aged 12-40 with intellectual and developmental disability (IDD) and/or autism spectrum disorder (ASD). Participants who are decisionally-impaired will be eligible with assent.
- •Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test
- •Be on a stable dose of psychotropic medication for at least one month prior to enrollment
- •Agree not to initiate new or change existing medications or behavior intervention
排除标准
- •Have an active implantable medical device (e.g., pacemaker, implanted hearing aid, etc.) or a metallic device, such as a stent, bone plate, or bone screw
- •Have a comorbid physical or psychiatric disorder which would disrupt ability to tolerate vagal stimulation or comply with study demands (e.g., insulin dependent diabetes, bipolar, etc.)
- •Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
- •Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury.
- •Current or recent (within 12 months) participation in a clinical trial of a drug or a medical device.
- •Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers, beta stimulant, etc.).
- •Use of marijuana (including medical marijuana) for any indication
- •Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy).
- •Lack of capacity to consent and without a legally authorized representative (LAR) who is a parent, spouse, or an adult child.
- •Living in a residential program (e.g., group home)
- •Wards of state
研究组 & 干预措施
Vagus Nerve Stimulation (VNS)
Single-subject design: ABA, ABBA, or ABBBA
This study allows for a flexibility in the duration of research participation depending on one's response. The participant will be able to select one of the three design options (1, 2, or 3 months of VNS twice per day) in consultation with the study staff. That is, after the initial 1-month trial of VNS, the participant may choose to extend the VNS two more times (i.e., 1 or 2 months), for a total of 90 days.
干预措施: Vagus Nerve Stimulation (Device)
结局指标
主要结局
Aberrant Behavior Checklist-Community (ABC-C)
时间窗: Change measured once per month for 3, 4, or 5 months
The ABC-C is a 58-item questionnaire consisting of five subscales: Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy. Minimum score = 0, maximum score = 174. Higher scores indicate more severity.
Behavior Rating Inventory of Executive Function (BRIEF)
时间窗: Change measured once per month for 3, 4, or 5 months
The BRIEF is an informant-based assessment that contains 63 (preschool age) 86 (school age) items with eight subdomains of executive function: 1) Inhibit, 2) Shift, and 3) Emotional Control subdomains together result in an additional composite Behavioral Regulation Index. The subdomains 4) Initiate, 5) Working Memory, 6) Plan/Organize, 7) Organization of Materials, and 8) Monitor provide a composite Metacognition Index. The indexes are also combined to obtain an overall Global Executive Composite. Higher T scores indicate more symptom severity.
Repetitive Behavior Scale-Revised (RBS-R)
时间窗: Change measured once per month for 3, 4, or 5 months
The RBS-R is a 44-item questionnaire that is used to measure the breadth of repetitive behavior in people with ASD. The RBS-R consists of six subscales including: Stereotyped, Self-injurious, Compulsive, Routine, Sameness, and Restricted Behaviors. Minimum score = 0; maximum score = 136. Higher scores indicate more severity.
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
时间窗: Change measured once per month for 3, 4, or 5 months
The PDDBI is an informant-based assessment that examines treatment effectiveness and differentiates ASD from other conditions. It consists of the following Approach/Withdrawal Problems: 1) Sensory/Perceptual Approach, 2) Ritualisms/Resistance to Change, 3) Social Pragmatic, 4) Semantic Pragmatic, 5) Arousal Regulation, 6) Specific Fears, 7) Aggressiveness. Under Receptive/ Expressive Social Communication Abilities, there are 1) Social Approach Behaviors, 2) Expressive Language, and 3) Learning, Memory, and Receptive Language. Higher T scores on Approach/Withdrawal Problems indicate more symptom severity and higher T scores on Receptive/Expressive Social Communication indicate more skills.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (Y-BOCS)
时间窗: Change measured once per month for 3, 4, or 5 months
The Y-BOCS is a measurement tool for OCD. It is not a diagnostic tool. Rather, it is a scale used to gauge the severity and nature of OCD symptoms and to monitor improvement. Higher scores indicate severity. Minimum score = 0; maximum score = 40. Higher scores indicate more severity.
The Symptom Checklist-90-Revised (SCL-90-R)
时间窗: Change measured once per month for 3, 4, or 5 months
The SCL-90-R is a questionnaire designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It is also useful in measuring treatment outcomes. Higher T scores indicate more symptom severity.
次要结局
- Neurocognitive assessment(Change measured once per month for 3, 4, or 5 months)
- Electro-encephalogram (EEG)(Change measured once per month for 3, 4, or 5 months)
- Biorhythmic motion measurements(Change measured once per month for 3, 4, or 5 months)