Tourette SyndromeNCT06576726
Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
An observational study of Tourette Syndrome and Tic Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome, Tic Disorder
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants must be willing to attend Visits 2 and 4 in-person
Who may be able to join
- 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
Who cannot join
- 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**
Show all 32Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Clinical Translational Research Coordinator II contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashvile, Tennessee, 37232
Michelle Clinical Translational Research Coordinator II, BS, 615-875-7394, michelle.r.eckland.1@vumc.org
David Isaacs, MD, MPH
About this study
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.
Read more
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.
Read the 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\' 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
- Tourette Syndrome, Tic Disorder
- Being tested
- This study involves no intervention.
- Keywords
- Tourette syndrome, tic disorder, sensorimotor, sensory, motor, sensory over-responsivity, psychosocial, development, behavioral, neurophysiology
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study involves no intervention.Other
This study involves no intervention.
| Study group | Role | What they receive |
|---|---|---|
| adolescents with tic disorder | Not described Receives: Other: This study involves no intervention. | |
| neurotypical adolescents (controls) | Not described Receives: Other: This study involves no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent/Adult Sensory Profile (AASP)
validated, 60-item self-report questionnaire assessing sensory experiences
Measured: from baseline to 2-year follow-up
Sensory Perception Quotient
35-item self-report questionnaire assessing self-perceived basic sensory sensitivity
Measured: from baseline to 2-year follow-up
Sensory Gating Inventory
validated, 36-item self-report questionnaire assessing sensory over-responsivity
Measured: from baseline to 2-year follow-up
Adolescent Motor Competence Questionnaire (AMCQ)
validated, 26-item self-report questionnaire assessing self-perceived coordination
Measured: from baseline to 2-year follow-up
Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2)
validated, rater-administered scale assessing motor coordination
Measured: from baseline to 2-year follow-up
Purdue pegboard
validated, rater-administered task assessing manual dexterity and coordination
Measured: from baseline to 2-year follow-up
Vibrotactile battery, with BrainGauge (CM4)
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
Measured: from baseline to 2-year follow-up
Tactile gating indices
Participants will undergo a tactile gating paradigm, while monitored on electroencephalogram (EEG), during which puffs of air will be administered to the index finger.
Measured: from baseline to 2-year follow-up
Contingent negative variation indices
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
Measured: from baseline to 2-year follow-up
Secondary outcomes (33)
Yale Global Tic Severity Scale (YGTSS)
gold-standard semi-structured interview assessing tic severity
Measured: from baseline to 2-year follow-up
Premonitory Urge for Tics Scale (PUTS)
validated, 10-item self-report questionnaire assessing premonitory urge severity
Measured: from baseline to 2-year follow-up
Adult ADHD Self-Report Scale for DSM-V (ASRS-V)
6-item self-report questionnaire assessing ADHD severity
Measured: from baseline to 2-year follow-up
Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)
validated, 18-item self-report questionnaire assessing OCD symptom severity
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a
8-item self-report scale assessing anxiety severity
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a
8-item self-report questionnaire assessing depression severity
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a
8-item self-report questionnaire assessing self-perceived peer relationship quality
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Family Relationships 8a
8-item self-report questionnaire assessing self-perceived family relationship quality
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a
8-item self-report questionnaire assessing self-perceived sleep quality
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a
8-item self-report questionnaire assessing meaning and purpose in life
Measured: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Life Satisfaction 8a
8-item self-report questionnaire assessing degree of satisfaction with life
Measured: from baseline to 2-year follow-up
Lubben Social Network Scale
12-item self-report scale assessing extent of individual's social network
Measured: from baseline to 2-year follow-up
UCLA Loneliness Scale
20-item self-report scale assessing loneliness
Measured: from baseline to 2-year follow-up
Height, weight, waist measurement
Height, weight, waist measurement
Measured: from baseline to 2-year follow-up
Beery Visuomotor Integration, 6th edition
validated, rater-administered measure assessing visuo-motor integration
Measured: from baseline to 2-year follow-up
Writing kinematic indices
Using MovAlyzeR software program on a Wacom tablet, the participant will perform several writing exercises to quantify writing kinematic characteristics.
Measured: from baseline to 2-year follow-up
Adolescent Stress and Adversity Inventory (STRAIN)
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."
Measured: from baseline to 2-year follow-up
Finger tapping indices
Participants will perform a finger tapping task, while monitored on electroencephalogram (EEG)
Measured: from baseline to 2-year follow-up
Child Behavior Checklist
validated, 113-item, proxy-report questionnaire assessing psychopathology in children and adolescents
Measured: from baseline to 2-year follow-up
Conners-4
validated, 117-item, proxy-report questionnaire assessing symptoms of ADHD and commonly co-occurring diagnoses of ADHD in children and adolescents
Measured: from baseline to 2-year follow-up
Toronto Obsessive-Compulsive Scale (TOCS)
validated, 21-item proxy-report questionnaire assessing OCD symptom severity
Measured: from baseline to 2-year follow-up
Social Communication Questionnaire - Lifetime
validated, 40-item proxy-report questionnaire assessing lifetime history of communication difficulties/differences and other symptoms suggestive of autism spectrum disorder
Measured: from basline to 2-year follow-up
BRIEF-2 Parent Form
validated, 63-item proxy-report questionnaire assessing executive dysfunction
Measured: from baseline to 2-year follow-up
PedsQL Family Impact Module, Version 2.0
validated, 36-item proxy-report questionnaire assessing impact of child's/adolescent's health on family
Measured: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a
8-item, proxy-report questionnaire assessing anxiety
Measured: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a
8-item, proxy-report questionnaire assessing depression
Measured: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a
7-item, proxy-report questionnaire assessing proxy-perceived peer relationship quality
Measured: from baseline to 2-year follow-up
PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a
4-item, proxy-report questionnaire assessing proxy-perceived family relationship quality
Measured: from baseline to 2-year follow-up
PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a
4-item, proxy-report questionnaire assessing proxy-perceived sleep disturbances
Measured: from baseline to 2-year follow-up
PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a
8-item, proxy-report questionnaire assessing proxy-perceived meaning and purpose in adolescent's life
Measured: from baseline to 2-year follow-up
PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a
8-item, proxy-report questionnaire assessing adolescent's satisfaction with life
Measured: from baseline to 2-year follow-up
Short Sensory Profile - 2
validated, 34-item proxy-report questionnaire assessing sensory experiences
Measured: from baseline to 2-year follow-up
Developmental Coordination Disorder Questionnaire
15-item proxy-report questionnaire assessing motor coordination
Measured: from baseline to 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start24 Oct 2024
- Primary completionAug 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Isaacs, Vanderbilt University Medical Center
- Investigators
- David Isaacs, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576726
- Sponsor's protocol ID
- 241465
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As per NIH guidelines, de-identified data will be shared in an established repository (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/repositories-for-sharing-scientific-data) no later than 12 months after the end of any proposed funding period or within 12 months of the last study visit, whichever comes first. The data sharing plan is not yet available in an online format.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
- ClinicalTrials.gov ID
- NCT06576726
- Acronym / sponsor ID
- 241465
- Conditions
- Tourette Syndrome, Tic Disorder
- Keywords
- Tourette syndrome, tic disorder, sensorimotor, sensory, motor, sensory over-responsivity, psychosocial, development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\' 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescents with tic disorder | – | Other: This study involves no intervention. |
| neurotypical adolescents (controls) | – | Other: This study involves no intervention. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants must be willing to attend Visits 2 and 4 in-person
Key inclusion criteria (4 listed)
Key exclusion criteria (32 listed)
- Additional exclusion criteria for EEG tasks for chronic tic disorder sample**
- Inclusion criteria for control (neurotypical adolescent) participants
- Note: adolescents with history of mood or anxiety disorder are eligible.
- Additional exclusion criteria for EEG tasks for control sample*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study involves no intervention.This study involves no intervention. | Other | adolescents with tic disorder, neurotypical adolescents (controls) |
Primary outcome
Adolescent/Adult Sensory Profile (AASP)
Time frame: from baseline to 2-year follow-up
validated, 60-item self-report questionnaire assessing sensory experiences
Sensory Perception Quotient
Time frame: from baseline to 2-year follow-up
35-item self-report questionnaire assessing self-perceived basic sensory sensitivity
Sensory Gating Inventory
Time frame: from baseline to 2-year follow-up
validated, 36-item self-report questionnaire assessing sensory over-responsivity
Adolescent Motor Competence Questionnaire (AMCQ)
Time frame: from baseline to 2-year follow-up
validated, 26-item self-report questionnaire assessing self-perceived coordination
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
Purdue pegboard
Time frame: from baseline to 2-year follow-up
validated, rater-administered task assessing manual dexterity and coordination
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
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.
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
33 secondary outcomes
Yale Global Tic Severity Scale (YGTSS)
Time frame: from baseline to 2-year follow-up
Premonitory Urge for Tics Scale (PUTS)
Time frame: from baseline to 2-year follow-up
Adult ADHD Self-Report Scale for DSM-V (ASRS-V)
Time frame: from baseline to 2-year follow-up
Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Depressive Sx 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF GenPop v3.0 - Peer Relationships 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Family Relationships 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Sleep Disturbance 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Meaning and Purpose 8a
Time frame: from baseline to 2-year follow-up
PROMIS Pediatric SF v1.0 - Life Satisfaction 8a
Time frame: from baseline to 2-year follow-up
Lubben Social Network Scale
Time frame: from baseline to 2-year follow-up
UCLA Loneliness Scale
Time frame: from baseline to 2-year follow-up
Height, weight, waist measurement
Time frame: from baseline to 2-year follow-up
Beery Visuomotor Integration, 6th edition
Time frame: from baseline to 2-year follow-up
Writing kinematic indices
Time frame: from baseline to 2-year follow-up
Adolescent Stress and Adversity Inventory (STRAIN)
Time frame: from baseline to 2-year follow-up
Finger tapping indices
Time frame: from baseline to 2-year follow-up
Child Behavior Checklist
Time frame: from baseline to 2-year follow-up
Conners-4
Time frame: from baseline to 2-year follow-up
Toronto Obsessive-Compulsive Scale (TOCS)
Time frame: from baseline to 2-year follow-up
Social Communication Questionnaire - Lifetime
Time frame: from basline to 2-year follow-up
BRIEF-2 Parent Form
Time frame: from baseline to 2-year follow-up
PedsQL Family Impact Module, Version 2.0
Time frame: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Anxiety 8a
Time frame: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Depressive Sx 8a
Time frame: from baseline to 2-year follow-up
PROMIS Parent Proxy SF GenPop v3.0 - Peer Relationships 7a
Time frame: from baseline to 2-year follow-up
PROMIS EC Parent-Report SF v1.0 - Social Relationships - Family Relationships 4a
Time frame: from baseline to 2-year follow-up
PROMIS EC Parent-Report SF v1.0 - Sleep Health - Disturbance 4a
Time frame: from baseline to 2-year follow-up
PROMIS Parent Proxy SF v1.0 - Meaning and Purpose 8a
Time frame: from baseline to 2-year follow-up
PROMIS Parent Proxy SF v1.0 - Life Satisfaction 8a
Time frame: from baseline to 2-year follow-up
Short Sensory Profile - 2
Time frame: from baseline to 2-year follow-up
Developmental Coordination Disorder Questionnaire
Time frame: from baseline to 2-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided. As per NIH guidelines, de-identified data will be shared in an established repository (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/repositories-for-sharing-scientific-data) no later than 12 months after the end of any proposed funding period or within 12 months of the last study visit, whichever comes first. The data sharing plan is not yet available in an online format.
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Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Clinical Translational Research Coordinator II contact
David Isaacs, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Tic Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Clinical Translational Research Coordinator II (615-875-7394, michelle.r.eckland.1@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent/Adult Sensory Profile (AASP) (time frame: from baseline to 2-year follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.