Sensorimotor and Psychosocial Trajectories in Adolescents with Tic Disorder
NCT Number: NCT06576726
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tourette Syndrome|Tic Disorder
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: CHILD
Enrollment: 351
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2030-05

Summary:
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.

Primary Outcome Measures: Adolescent/Adult Sensory Profile (AASP), validated, 60-item self-report questionnaire assessing sensory experiences, from baseline to 2-year follow-up|Sensory Perception Quotient, 35-item self-report questionnaire assessing self-perceived basic sensory sensitivity, from baseline to 2-year follow-up|Sensory Gating Inventory, validated, 36-item self-report questionnaire assessing sensory over-responsivity, from baseline to 2-year follow-up|Adolescent Motor Competence Questionnaire (AMCQ), validated, 26-item self-report questionnaire assessing self-perceived coordination, from baseline to 2-year follow-up|Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2), validated, rater-administered scale assessing motor coordination, from baseline to 2-year follow-up|Purdue pegboard, validated, rater-administered task assessing manual dexterity and coordination, from baseline to 2-year follow-up|Vibrotactile battery, with BrainGauge (CM4), 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, from baseline to 2-year follow-up|Tactile gating indices, Participants will undergo a tactile gating paradigm, while monitored on electroencephalogram (EEG), during which puffs of air will be administered to the index finger., from baseline to 2-year follow-up|Contingent negative variation indices, 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, from baseline to 2-year follow-up
Secondary Outcome Measures: Yale Global Tic Severity Scale (YGTSS), gold-standard semi-structured interview assessing tic severity, from baseline to 2-year follow-up|Premonitory Urge for Tics Scale (PUTS), validated, 10-item self-report questionnaire assessing premonitory urge severity, from baseline to 2-year follow-up|Adult ADHD Self-Report Scale for DSM-V (ASRS-V), 6-item self-report questionnaire assessing ADHD severity, from baseline to 2-year follow-up|Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R), validated, 18-item self-report questionnaire assessing OCD symptom severity, from baseline to 2-year follow-up|PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a, 8-item self-report scale assessing anxiety severity, from baseline to 2-year follow-up|PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a, 8-item self-report questionnaire assessing depression severity, from baseline to 2-year follow-up|PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a, 8-item self-report questionnaire assessing self-perceived peer relationship quality, from baseline to 2-year follow-up|PROMIS Pediatric SF v1.0 - Family Relationships 8a, 8-item self-report questionnaire assessing self-perceived family relationship quality, from baseline to 2-year follow-up|PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a, 8-item self-report questionnaire assessing self-perceived sleep quality, from baseline to 2-year follow-up|PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a, 8-item self-report questionnaire assessing meaning and purpose in life, from baseline to 2-year follow-up|PROMIS Pediatric SF v1.0 - Life Satisfaction 8a, 8-item self-report questionnaire assessing degree of satisfaction with life, from baseline to 2-year follow-up|Lubben Social Network Scale, 12-item self-report scale assessing extent of individual's social network, from baseline to 2-year follow-up|UCLA Loneliness Scale, 20-item self-report scale assessing loneliness, from baseline to 2-year follow-up|Height, weight, waist measurement, Height, weight, waist measurement, from baseline to 2-year follow-up|Beery Visuomotor Integration, 6th edition, validated, rater-administered measure assessing visuo-motor integration, from baseline to 2-year follow-up|Writing kinematic indices, Using MovAlyzeR software program on a Wacom tablet, the participant will perform several writing exercises to quantify writing kinematic characteristics., from baseline to 2-year follow-up|Adolescent Stress and Adversity Inventory (STRAIN), Per the scale developer's website: "The Stress and Adversity Inventory (STRAIN) is an NIMH/RDoC-recommended instrument for efficiently and reliably assessing exposure to acute and chronic life stress over the life course. The measure is entirely online and systematically inquires about a diverse array of acute life events (e.g., deaths of relatives, job losses, negative health events) and chronic difficulties (e.g., ongoing health problems, work problems, relationship problems, financial problems, etc.) that have implications for human health and well-being. Stressors occurring in early life (e.g., childhood maltreatment or neglect, parental loss/separation, etc.) are also queried. Participants are asked to rate the severity, frequency, timing, and duration of each stressor they endorse...Based on this information, the system produces 455 variables that are used to assess an individual's cumulative exposure to stress.", from baseline to 2-year follow-up|Finger tapping indices, Participants will perform a finger tapping task, while monitored on electroencephalogram (EEG), from baseline to 2-year follow-up|Child Behavior Checklist, validated, 113-item, proxy-report questionnaire assessing psychopathology in children and adolescents, from baseline to 2-year follow-up|Conners-4, validated, 117-item, proxy-report questionnaire assessing symptoms of ADHD and commonly co-occurring diagnoses of ADHD in children and adolescents, from baseline to 2-year follow-up|Toronto Obsessive-Compulsive Scale (TOCS), validated, 21-item proxy-report questionnaire assessing OCD symptom severity, from baseline to 2-year follow-up|Social Communication Questionnaire - Lifetime, validated, 40-item proxy-report questionnaire assessing lifetime history of communication difficulties/differences and other symptoms suggestive of autism spectrum disorder, from basline to 2-year follow-up|BRIEF-2 Parent Form, validated, 63-item proxy-report questionnaire assessing executive dysfunction, from baseline to 2-year follow-up|PedsQL Family Impact Module, Version 2.0, validated, 36-item proxy-report questionnaire assessing impact of child's/adolescent's health on family, from baseline to 2-year follow-up|PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a, 8-item, proxy-report questionnaire assessing anxiety, from baseline to 2-year follow-up|PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a, 8-item, proxy-report questionnaire assessing depression, from baseline to 2-year follow-up|PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a, 7-item, proxy-report questionnaire assessing proxy-perceived peer relationship quality, from baseline to 2-year follow-up|PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a, 4-item, proxy-report questionnaire assessing proxy-perceived family relationship quality, from baseline to 2-year follow-up|PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a, 4-item, proxy-report questionnaire assessing proxy-perceived sleep disturbances, from baseline to 2-year follow-up|PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a, 8-item, proxy-report questionnaire assessing proxy-perceived meaning and purpose in adolescent's life, from baseline to 2-year follow-up|PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a, 8-item, proxy-report questionnaire assessing adolescent's satisfaction with life, from baseline to 2-year follow-up
Other Outcome Measures: Edinburgh Handedness Inventory - Short Version, 4-item self-report questionnaire to assess extent of individual's left- or right-handed dominance, from baseline to 2-year follow-up|Pubertal Development Scale, 5-item self-report scale assessing pubertal stage, based on self-reported signs, from baseline to 2-year follow-up|Weschler Abbreviated Scale of Intelligence, 2nd edition (WASI-II), 2-subtest with Vocabulary and Matrix Reasoning, validated, rater-administered measure assessing intelligence, baseline|UCLA Loneliness Scale (Adult Proxy), 20-item self-report questionnaire assessing loneliness, from baseline to 2-year follow-up|PROMIS SF v1.0 - Anxiety 8a (Adult Proxy), 8-item, self-report questionnaire assessing adult proxy's anxiety, from baseline to 2-year follow-up|PROMIS SF v1.0 - Depression 8a (Adult Proxy), 8-item, self-report questionnaire assessing adult proxy's depression, from baseline to 2-year follow-up|Perceived Stress Scale (Adult Proxy), 10-item self-report questionnaire assessing adult proxy's self-perceived stress, from baseline to 2-year follow-up|Interpersonal Support Evaluation List (Adult Proxy), 12-item self-report questionnaire assessing adult proxy's self-perceived social support, from baseline to 2-year follow-up