Clinical trial NCT06576726: Sensorimotor and Psychosocial Trajectories in Adolescents with Tic Disorder
Official title: Sensorimotor and Psychosocial Trajectories in Adolescents with Tic Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tourette Syndrome
Tic Disorder
Keywords: Tourette syndrome
tic disorder
sensorimotor
sensory
motor
sensory over-responsivity
psychosocial
development
behavioral
neurophysiology
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 351
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be willing to attend Visits 2 and 4 in-person

Brief 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.

Detailed description: 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\&#39; motor coordination, handwriting, and intelligence will be assessed using various tasks and scales. This will take about 2 hours and 30 minutes. Additionally, adolescents\&#39; 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.

Eligibility criteria: * Inclusion criteria for adolescents with tic disorder:

  * adolescent age 11-17 years of age
  * adolescent diagnosis of chronic tic disorder (Tourette syndrome, chronic motor tic disorder, chronic vocal tic disorder)
  * English-speaking adolescent and caregiver/adult proxy (as validated questionnaires are in English)
  * adolescent and caregiver/adult proxy willingness and ability to complete relevant questionnaires
* Exclusion criteria for for adolescents with tic disorder:

  * cognitive or attentional impairment precluding ability of adolescent or caregiver/adult proxy to complete questionnaires and other study measures
  * adolescent diagnosis of autism spectrum disorder (ASD) or psychotic disorder
  * adolescent diagnosis of pervasive genetic disorder besides chronic tic disorders and their known comorbidities
  * adolescent with severe medical conditions unrelated to chronic tic disorders (e.g. uncontrolled seizures, prominent heart conditions)
  * other variables that might influence ratings outside of the typical presentation of chronic tic disorders
* Additional exclusion criteria for EEG tasks for chronic tic disorder sample\*\*

  * adolescent treatment with stimulant medications or anti-seizure medications within the past 30 days
  * use of marijuana or recreational substances within the past 30 days
  * history of seizure
  * history of hearing loss or abnormalities
  * history of neuropathy or overt sensory deficit
  * history of brain surgery or skull-penetrating/deforming trauma
  * history of stroke, brain cancer, or other significant neurologic illness/disorder \*\* Individuals excluded based on these criteria are ineligible for the EEG portion of the study but can complete the remainder of the study measures.
* Inclusion criteria for control (neurotypical adolescent) participants

  * adolescent age 11-17 years of age
  * English-speaking adolescent and caregiver/adult proxy (as validated questionnaires are in English)
  * adolescent and caregiver/adult proxy willingness and ability to complete relevant questionnaires
* Exclusion criteria for control sample

  * history of tics, ADHD, OCD, or other significant neurodevelopmental or neuropsychiatric disorder.

    \*\* Note: adolescents with history of mood or anxiety disorder are eligible.
  * cognitive or attentional impairment precluding ability of adolescent or caregiver/adult proxy to complete questionnaires and other study measures
  * adolescent diagnosis of autism spectrum disorder (ASD) or psychotic disorder
  * adolescent diagnosis of pervasive genetic disorder
  * adolescent with severe medical conditions (e.g. uncontrolled seizures, prominent heart conditions)
  * other variables that might influence ratings
* Additional exclusion criteria for EEG tasks for control sample\*

  * adolescent treatment with stimulant medications or anti-seizure medications within the past 30 days
  * use of marijuana or recreational substances within the past 30 days
  * history of seizure
  * history of hearing loss or abnormalities
  * history of neuropathy or overt sensory deficit
  * history of brain surgery or skull-penetrating/deforming trauma
  * history of stroke, brain cancer, or other significant neurologic illness/disorder

Primary outcomes:
measure: Adolescent/Adult Sensory Profile (AASP)
timeFrame: from baseline to 2-year follow-up
measure: Sensory Perception Quotient
timeFrame: from baseline to 2-year follow-up
measure: Sensory Gating Inventory
timeFrame: from baseline to 2-year follow-up
measure: Adolescent Motor Competence Questionnaire (AMCQ)
timeFrame: from baseline to 2-year follow-up
measure: Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2)
timeFrame: from baseline to 2-year follow-up
measure: Purdue pegboard
timeFrame: from baseline to 2-year follow-up
measure: Vibrotactile battery, with BrainGauge (CM4)
timeFrame: from baseline to 2-year follow-up
measure: Tactile gating indices
timeFrame: from baseline to 2-year follow-up
measure: Contingent negative variation indices
timeFrame: from baseline to 2-year follow-up
Secondary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: from baseline to 2-year follow-up
measure: Premonitory Urge for Tics Scale (PUTS)
timeFrame: from baseline to 2-year follow-up
measure: Adult ADHD Self-Report Scale for DSM-V (ASRS-V)
timeFrame: from baseline to 2-year follow-up
measure: Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF v1.0 - Family Relationships 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Pediatric SF v1.0 - Life Satisfaction 8a
timeFrame: from baseline to 2-year follow-up
measure: Lubben Social Network Scale
timeFrame: from baseline to 2-year follow-up
measure: UCLA Loneliness Scale
timeFrame: from baseline to 2-year follow-up
measure: Height, weight, waist measurement
timeFrame: from baseline to 2-year follow-up
measure: Beery Visuomotor Integration, 6th edition
timeFrame: from baseline to 2-year follow-up
measure: Writing kinematic indices
timeFrame: from baseline to 2-year follow-up
measure: Adolescent Stress and Adversity Inventory (STRAIN)
timeFrame: from baseline to 2-year follow-up
measure: Finger tapping indices
timeFrame: from baseline to 2-year follow-up
measure: Child Behavior Checklist
timeFrame: from baseline to 2-year follow-up
measure: Conners-4
timeFrame: from baseline to 2-year follow-up
measure: Toronto Obsessive-Compulsive Scale (TOCS)
timeFrame: from baseline to 2-year follow-up
measure: Social Communication Questionnaire - Lifetime
timeFrame: from basline to 2-year follow-up
measure: BRIEF-2 Parent Form
timeFrame: from baseline to 2-year follow-up
measure: PedsQL Family Impact Module, Version 2.0
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a
timeFrame: from baseline to 2-year follow-up
measure: PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a
timeFrame: from baseline to 2-year follow-up
measure: Short Sensory Profile - 2
timeFrame: from baseline to 2-year follow-up
measure: Developmental Coordination Disorder Questionnaire
timeFrame: from baseline to 2-year follow-up
Other outcomes:
measure: Edinburgh Handedness Inventory - Short Version
timeFrame: from baseline to 2-year follow-up
measure: Pubertal Development Scale
timeFrame: from baseline to 2-year follow-up
measure: Weschler Abbreviated Scale of Intelligence, 2nd edition (WASI-II), 2-subtest with Vocabulary and Matrix Reasoning
timeFrame: baseline
measure: UCLA Loneliness Scale (Adult Proxy)
timeFrame: from baseline to 2-year follow-up
measure: PROMIS SF v1.0 - Anxiety 8a (Adult Proxy)
timeFrame: from baseline to 2-year follow-up
measure: PROMIS SF v1.0 - Depression 8a (Adult Proxy)
timeFrame: from baseline to 2-year follow-up
measure: Perceived Stress Scale (Adult Proxy)
timeFrame: from baseline to 2-year follow-up
measure: Interpersonal Support Evaluation List (Adult Proxy)
timeFrame: from baseline to 2-year follow-up
Locations:
city: Nashvile
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Isaacs, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: