NCT06576726 Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
| NCT ID | NCT06576726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Tourette Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 351 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 351 participants in total. It began in 2024-10-24 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Michelle Clinical Translational Research Coordinator II
✉ michelle.r.eckland.1@vumc.org📞 615-875-7394
David Isaacs, MD, MPH
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06576726 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Tourette Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576726 currently recruiting?
Yes, NCT06576726 is actively recruiting participants. Contact the research team at michelle.r.eckland.1@vumc.org for enrollment information.
Where is the NCT06576726 trial being conducted?
This trial is being conducted at Nashvile, United States.
Who is sponsoring the NCT06576726 clinical trial?
NCT06576726 is sponsored by Vanderbilt University Medical Center. The principal investigator is David Isaacs, MD, MPH at Vanderbilt University Medical Center. The trial plans to enroll 351 participants.