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NCT Number: NCT06576726

Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder

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.

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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashvile, Tennessee, 37232, United States

Location status: Recruiting

Location contact

David Isaacs, MD, MPH

PRINCIPAL_INVESTIGATOR

Michelle Clinical Translational Research Coordinator II, BS

CONTACT

[email protected]

615-875-7394

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

This study involves no intervention.

Other

This study involves no intervention.

Primary outcomes

  1. Adolescent/Adult Sensory Profile (AASP)

    Time frame: from baseline to 2-year follow-up

    validated, 60-item self-report questionnaire assessing sensory experiences

  2. Sensory Perception Quotient

    Time frame: from baseline to 2-year follow-up

    35-item self-report questionnaire assessing self-perceived basic sensory sensitivity

  3. Sensory Gating Inventory

    Time frame: from baseline to 2-year follow-up

    validated, 36-item self-report questionnaire assessing sensory over-responsivity

  4. Adolescent Motor Competence Questionnaire (AMCQ)

    Time frame: from baseline to 2-year follow-up

    validated, 26-item self-report questionnaire assessing self-perceived coordination

  5. Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2)

    Time frame: from baseline to 2-year follow-up

    validated, rater-administered scale assessing motor coordination

  6. Purdue pegboard

    Time frame: from baseline to 2-year follow-up

    validated, rater-administered task assessing manual dexterity and coordination

  7. Vibrotactile battery, with BrainGauge (CM4)

    Time frame: 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

  8. Tactile gating indices

    Time frame: 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.

  9. Contingent negative variation indices

    Time frame: 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

Secondary outcomes

  1. Yale Global Tic Severity Scale (YGTSS)

    Time frame: from baseline to 2-year follow-up

    gold-standard semi-structured interview assessing tic severity

  2. Premonitory Urge for Tics Scale (PUTS)

    Time frame: from baseline to 2-year follow-up

    validated, 10-item self-report questionnaire assessing premonitory urge severity

  3. Adult ADHD Self-Report Scale for DSM-V (ASRS-V)

    Time frame: from baseline to 2-year follow-up

    6-item self-report questionnaire assessing ADHD severity

  4. Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)

    Time frame: from baseline to 2-year follow-up

    validated, 18-item self-report questionnaire assessing OCD symptom severity

  5. PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report scale assessing anxiety severity

  6. PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing depression severity

  7. PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing self-perceived peer relationship quality

  8. PROMIS Pediatric SF v1.0 - Family Relationships 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing self-perceived family relationship quality

  9. PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing self-perceived sleep quality

  10. PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing meaning and purpose in life

  11. PROMIS Pediatric SF v1.0 - Life Satisfaction 8a

    Time frame: from baseline to 2-year follow-up

    8-item self-report questionnaire assessing degree of satisfaction with life

  12. Lubben Social Network Scale

    Time frame: from baseline to 2-year follow-up

    12-item self-report scale assessing extent of individual's social network

  13. UCLA Loneliness Scale

    Time frame: from baseline to 2-year follow-up

    20-item self-report scale assessing loneliness

  14. Height, weight, waist measurement

    Time frame: from baseline to 2-year follow-up

    Height, weight, waist measurement

  15. Beery Visuomotor Integration, 6th edition

    Time frame: from baseline to 2-year follow-up

    validated, rater-administered measure assessing visuo-motor integration

  16. Writing kinematic indices

    Time frame: from baseline to 2-year follow-up

    Using MovAlyzeR software program on a Wacom tablet, the participant will perform several writing exercises to quantify writing kinematic characteristics.

  17. Adolescent Stress and Adversity Inventory (STRAIN)

    Time frame: from baseline to 2-year follow-up

    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."

  18. Finger tapping indices

    Time frame: from baseline to 2-year follow-up

    Participants will perform a finger tapping task, while monitored on electroencephalogram (EEG)

  19. Child Behavior Checklist

    Time frame: from baseline to 2-year follow-up

    validated, 113-item, proxy-report questionnaire assessing psychopathology in children and adolescents

  20. Conners-4

    Time frame: from baseline to 2-year follow-up

    validated, 117-item, proxy-report questionnaire assessing symptoms of ADHD and commonly co-occurring diagnoses of ADHD in children and adolescents

  21. Toronto Obsessive-Compulsive Scale (TOCS)

    Time frame: from baseline to 2-year follow-up

    validated, 21-item proxy-report questionnaire assessing OCD symptom severity

  22. Social Communication Questionnaire - Lifetime

    Time frame: from basline to 2-year follow-up

    validated, 40-item proxy-report questionnaire assessing lifetime history of communication difficulties/differences and other symptoms suggestive of autism spectrum disorder

  23. BRIEF-2 Parent Form

    Time frame: from baseline to 2-year follow-up

    validated, 63-item proxy-report questionnaire assessing executive dysfunction

  24. PedsQL Family Impact Module, Version 2.0

    Time frame: from baseline to 2-year follow-up

    validated, 36-item proxy-report questionnaire assessing impact of child's/adolescent's health on family

  25. PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a

    Time frame: from baseline to 2-year follow-up

    8-item, proxy-report questionnaire assessing anxiety

  26. PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a

    Time frame: from baseline to 2-year follow-up

    8-item, proxy-report questionnaire assessing depression

  27. PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a

    Time frame: from baseline to 2-year follow-up

    7-item, proxy-report questionnaire assessing proxy-perceived peer relationship quality

  28. PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a

    Time frame: from baseline to 2-year follow-up

    4-item, proxy-report questionnaire assessing proxy-perceived family relationship quality

  29. PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a

    Time frame: from baseline to 2-year follow-up

    4-item, proxy-report questionnaire assessing proxy-perceived sleep disturbances

  30. PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a

    Time frame: from baseline to 2-year follow-up

    8-item, proxy-report questionnaire assessing proxy-perceived meaning and purpose in adolescent's life

  31. PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a

    Time frame: from baseline to 2-year follow-up

    8-item, proxy-report questionnaire assessing adolescent's satisfaction with life

  32. Short Sensory Profile - 2

    Time frame: from baseline to 2-year follow-up

    validated, 34-item proxy-report questionnaire assessing sensory experiences

  33. Developmental Coordination Disorder Questionnaire

    Time frame: from baseline to 2-year follow-up

    15-item proxy-report questionnaire assessing motor coordination

Other outcomes

  1. Edinburgh Handedness Inventory - Short Version

    Time frame: from baseline to 2-year follow-up

    4-item self-report questionnaire to assess extent of individual's left- or right-handed dominance

  2. Pubertal Development Scale

    Time frame: from baseline to 2-year follow-up

    5-item self-report scale assessing pubertal stage, based on self-reported signs

  3. Weschler Abbreviated Scale of Intelligence, 2nd edition (WASI-II), 2-subtest with Vocabulary and Matrix Reasoning

    Time frame: baseline

    validated, rater-administered measure assessing intelligence

  4. UCLA Loneliness Scale (Adult Proxy)

    Time frame: from baseline to 2-year follow-up

    20-item self-report questionnaire assessing loneliness

  5. PROMIS SF v1.0 - Anxiety 8a (Adult Proxy)

    Time frame: from baseline to 2-year follow-up

    8-item, self-report questionnaire assessing adult proxy's anxiety

  6. PROMIS SF v1.0 - Depression 8a (Adult Proxy)

    Time frame: from baseline to 2-year follow-up

    8-item, self-report questionnaire assessing adult proxy's depression

  7. Perceived Stress Scale (Adult Proxy)

    Time frame: from baseline to 2-year follow-up

    10-item self-report questionnaire assessing adult proxy's self-perceived stress

  8. Interpersonal Support Evaluation List (Adult Proxy)

    Time frame: from baseline to 2-year follow-up

    12-item self-report questionnaire assessing adult proxy's self-perceived social support

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Clinical Translational Research Coordinator II

CONTACT

[email protected]

615-875-7394

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Aug 29, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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