Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06576726

Conditions

Tourette Syndrome

Tic Disorder

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

Interventions

This study involves no intervention.

Study Details

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.

Conditions

Tourette Syndrome

Tic Disorder

Study ID

NCT06576726

Start date

Oct 24, 2024

Status verified date

Nov, 2025

Completion date

May, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

351 participants

Anticipated

Interventions and Outcome Measures

Arms

adolescents with tic disorder

neurotypical adolescents (controls)

Interventions

This study involves no intervention.

This study involves no intervention.

Primary outcome measure

  • Adolescent/Adult Sensory Profile (AASP) [ Time Frame: from baseline to 2-year follow-up ]
  • Sensory Perception Quotient [ Time Frame: from baseline to 2-year follow-up ]
  • Sensory Gating Inventory [ Time Frame: from baseline to 2-year follow-up ]
  • Adolescent Motor Competence Questionnaire (AMCQ) [ Time Frame: from baseline to 2-year follow-up ]
  • Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2) [ Time Frame: from baseline to 2-year follow-up ]
  • Purdue pegboard [ Time Frame: from baseline to 2-year follow-up ]
  • Vibrotactile battery, with BrainGauge (CM4) [ Time Frame: from baseline to 2-year follow-up ]
  • Tactile gating indices [ Time Frame: from baseline to 2-year follow-up ]
  • Contingent negative variation indices [ Time Frame: from baseline to 2-year follow-up ]

Central Contacts and Locations

Central contacts

Michelle Clinical Translational Research Coordinator II

615-875-7394michelle.r.eckland.1@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashvile, Tennessee, United States, 37232

Contacts

Michelle Clinical Translational Research Coordinator II, BS

615-875-7394michelle.r.eckland.1@vumc.org

Principal Investigator:

David Isaacs, MD, MPH

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Tourette syndrome
  • tic disorder
  • sensorimotor
  • sensory
  • motor
  • sensory over-responsivity
  • psychosocial
  • development
  • behavioral
  • neurophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-11-24.