Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Adolescent/Adult Sensory Profile (AASP)
研究概览
简要总结
Individuals with tic disorders have lower quality of life, sensory and movement difficulties, and poorer mental, social, and physical health compared to the general population. Current clinical care for individuals with tic disorders is limited: no interventions are proven to prevent or stop the disorder exist, and most treatments focus solely on tics, though other symptoms often affect quality of life more than tics. To develop new treatments and improve care for people with tics, researchers need to better understand the different symptoms people experience and how the brain causes these symptoms.
Many individuals with tic disorders have sensory and movement symptoms other than tics. A common sensory symptom is increased sensitivity to common sensations, such as glare from sunlight, tags in shirt collars, and noises from passing cars. A common movement symptom is poor handwriting and/or poor coordination. In one study of adolescents with tic disorder, difficulty with hand coordination predicted tic severity 7.5 years later, suggesting that sensory and/or motor difficulties may be a risk factor for more severe tics later in life. Despite how common they are, much is unknown about sensory and motor difficulties experienced by people with tic disorders.
Additionally, most studies of people with tics enroll younger children. As a result, little is known about sensory, motor, and psychosocial development in adolescents with tics. Knowledge of sensory and motor difficulties in adolescents with tics is important to understand because, in other adolescent populations, such difficulties are associated with worse mental and social health and worse quality of life. Deepening insight into the sensory, motor, and psychosocial development of adolescents with tic disorders is crucial to identify causes and risk factors for poor health in this population.
The goals of this study are to measure sensory and motor symptoms and function in adolescents with tics and to compare them to adolescents without tics. The research team will enroll adolescents with tics and adolescents without tics to participate in the study. Adolescent participants will complete questionnaires, electroencephalogram (EEG) tasks, and other sensory and motor tasks at baseline (with 2 study visits occurring within 30 days of each other) and 2 years later (again, with 2 study visits, occurring within 30 days of each other). A parent or other adult who knows the adolescent well will also complete questionnaires as part of the study.
详细描述
The study consists of 4 visits over the course of 2 years. The first 2 visits will occur within 30 days of each other, and then, two years later, participants will be asked to attend two more study visits (again within 30 days of each other).
Study Visit 1 can occur in-person or remotely. If you and your adolescent prefer the remote visit, this will be conducted over Zoom, Microsoft Teams, or another commercial audiovisual platform. During Visit 1, adolescents will be interviewed by a trained rater to assess for tics, obsessive-compulsive disorder (OCD), and attention-deficit/hyperactivity disorder (ADHD). The interview will take about 1 hour. Adolescents will then be asked to complete a series of online questionnaires, asking about sensory experiences, coordination, puberty, mental health, and social health. The questionnaires will take about 1.5 hours to complete. In total Visit 1 will take about 2 hours and 30 minutes.
Study Visit 2 will occur in-person within 30 days of Visit 1. During Visit 2, adolescents will complete questionnaires about sensory experiences, stress, and other symptoms of tic disorders. Questionnaires will take about 1 hour to complete. Then, adolescents' motor coordination, handwriting, and intelligence will be assessed using various tasks and scales. This will take about 2 hours and 30 minutes. Additionally, adolescents' height, weight, and waste circumference will be measured. At the end of the visit, adolescents who are eligible will have an electroencephalogram (EEG) during which their brain activity will be measured while they experience different sensory stimuli (such as puffs of air, simple sounds) and perform different simple motor tasks (such as tapping). The EEG tasks will take about 1 hour and 30 minutes. In total, Visit 2 will take about 5 hours for adolescents eligible for EEG procedures; Visit 2 will take about 3 hours and 30 minutes for adolescents not eligible for EEG procedures. While the adolescent is being assessed, a parent or other adult caregiver will complete questionnaires about the adolescent and themselves; these questionnaires, which take a total of 2 hours to complete, ask about mental health, social health, and quality of life.
Study Visit 3 will occur 2 years after Study Visit 1. Visit 3 can occur in-person or remotely. Visit 3 procedures are identical to Visit 1 procedures.
Study Visit 4 will occur in-person within 30 days of Visit 3. Visit 4 procedures are identical to Visit 2 procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adolescent/Adult Sensory Profile (AASP)
时间窗: from baseline to 2-year follow-up
validated, 60-item self-report questionnaire assessing sensory experiences
Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2)
时间窗: from baseline to 2-year follow-up
validated, rater-administered scale assessing motor coordination
Vibrotactile battery, with BrainGauge (CM4)
时间窗: from baseline to 2-year follow-up
Device- and rater-administered battery assessing several features of vibrotactile threshold perception, including static threshold detection, dynamic threshold detection, amplitude discrimination without and with adaptation, sequential and simultaneous frequency discrimination
Contingent negative variation indices
时间窗: from baseline to 2-year follow-up
Participants will undergo a contingent negative variation paradigm, while monitored on electroencephalogram (EEG), during which puffs of air will be administered to the index finger, cueing the participant to respond
Adolescent Motor Competence Questionnaire (AMCQ)
时间窗: from baseline to 2-year follow-up
validated, 26-item self-report questionnaire assessing self-perceived coordination
Tactile gating indices
时间窗: from baseline to 2-year follow-up
Participants will undergo a tactile gating paradigm, while monitored on electroencephalogram (EEG), during which puffs of air will be administered to the index finger.
Sensory Perception Quotient
时间窗: from baseline to 2-year follow-up
35-item self-report questionnaire assessing self-perceived basic sensory sensitivity
Sensory Gating Inventory
时间窗: from baseline to 2-year follow-up
validated, 36-item self-report questionnaire assessing sensory over-responsivity
Purdue pegboard
时间窗: from baseline to 2-year follow-up
validated, rater-administered task assessing manual dexterity and coordination
次要结局
- Yale Global Tic Severity Scale (YGTSS)(from baseline to 2-year follow-up)
- Premonitory Urge for Tics Scale (PUTS)(from baseline to 2-year follow-up)
- Adult ADHD Self-Report Scale for DSM-V (ASRS-V)(from baseline to 2-year follow-up)
- Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)(from baseline to 2-year follow-up)
- PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF v1.0 - Family Relationships 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a(from baseline to 2-year follow-up)
- PROMIS Pediatric SF v1.0 - Life Satisfaction 8a(from baseline to 2-year follow-up)
- Lubben Social Network Scale(from baseline to 2-year follow-up)
- UCLA Loneliness Scale(from baseline to 2-year follow-up)
- Height, weight, waist measurement(from baseline to 2-year follow-up)
- Beery Visuomotor Integration, 6th edition(from baseline to 2-year follow-up)
- Writing kinematic indices(from baseline to 2-year follow-up)
- Adolescent Stress and Adversity Inventory (STRAIN)(from baseline to 2-year follow-up)
- Finger tapping indices(from baseline to 2-year follow-up)
- Child Behavior Checklist(from baseline to 2-year follow-up)
- Conners-4(from baseline to 2-year follow-up)
- Toronto Obsessive-Compulsive Scale (TOCS)(from baseline to 2-year follow-up)
- Social Communication Questionnaire - Lifetime(from basline to 2-year follow-up)
- BRIEF-2 Parent Form(from baseline to 2-year follow-up)
- PedsQL Family Impact Module, Version 2.0(from baseline to 2-year follow-up)
- PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a(from baseline to 2-year follow-up)
- PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a(from baseline to 2-year follow-up)
- PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a(from baseline to 2-year follow-up)
- PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a(from baseline to 2-year follow-up)
- PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a(from baseline to 2-year follow-up)
- PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a(from baseline to 2-year follow-up)
- PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a(from baseline to 2-year follow-up)
- Short Sensory Profile - 2(from baseline to 2-year follow-up)
- Developmental Coordination Disorder Questionnaire(from baseline to 2-year follow-up)
研究者
David Isaacs
Assistant Professor of Neurology and Pediatrics
Vanderbilt University Medical Center
