Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
NCT ID: NCT06576726
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
351 participants
OBSERVATIONAL
2024-10-24
2030-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neural Correlates of Sensory Phenomena in Tourette Syndrome
NCT03914664
Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement
NCT00056420
Multimodal Electrophysiological Study of Cortico-subcortical Biomarkers of Tics in Tourette Syndrome
NCT06909656
Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
NCT00755339
Hypersensitivity in Tourette Syndrome
NCT00368433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
adolescents with tic disorder
This study involves no intervention.
This study involves no intervention.
neurotypical adolescents (controls)
This study involves no intervention.
This study involves no intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
This study involves no intervention.
This study involves no intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
* 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.
* 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
* 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
11 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Isaacs
Assistant Professor of Neurology and Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Isaacs, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashvile, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Michelle Clinical Translational Research Coordinator II
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Michelle Clinical Translational Research Coordinator II, BS
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
241465
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.