- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michelle Clinical Translational Research Coordinator II
- Phone Number: 615-875-7394
- Email: michelle.r.eckland.1@vumc.org
Study Locations
-
-
Tennessee
-
Nashvile, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Principal Investigator:
- David Isaacs, MD, MPH
-
Contact:
- Michelle Clinical Translational Research Coordinator II, BS
- Phone Number: 615-875-7394
- Email: michelle.r.eckland.1@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adolescents with tic disorder
|
This study involves no intervention.
|
|
neurotypical adolescents (controls)
|
This study involves no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent/Adult Sensory Profile (AASP)
Time Frame: from baseline to 2-year follow-up
|
validated, 60-item self-report questionnaire assessing sensory experiences
|
from baseline to 2-year follow-up
|
|
Sensory Perception Quotient
Time Frame: from baseline to 2-year follow-up
|
35-item self-report questionnaire assessing self-perceived basic sensory sensitivity
|
from baseline to 2-year follow-up
|
|
Sensory Gating Inventory
Time Frame: from baseline to 2-year follow-up
|
validated, 36-item self-report questionnaire assessing sensory over-responsivity
|
from baseline to 2-year follow-up
|
|
Adolescent Motor Competence Questionnaire (AMCQ)
Time Frame: from baseline to 2-year follow-up
|
validated, 26-item self-report questionnaire assessing self-perceived coordination
|
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
|
validated, rater-administered scale assessing motor coordination
|
from baseline to 2-year follow-up
|
|
Purdue pegboard
Time Frame: from baseline to 2-year follow-up
|
validated, rater-administered task assessing manual dexterity and coordination
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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.
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale Global Tic Severity Scale (YGTSS)
Time Frame: from baseline to 2-year follow-up
|
gold-standard semi-structured interview assessing tic severity
|
from baseline to 2-year follow-up
|
|
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
|
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
|
6-item self-report questionnaire assessing ADHD severity
|
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
|
validated, 18-item self-report questionnaire assessing OCD symptom severity
|
from baseline to 2-year follow-up
|
|
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
|
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
|
8-item self-report questionnaire assessing depression severity
|
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
|
8-item self-report questionnaire assessing self-perceived peer relationship quality
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
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
|
8-item self-report questionnaire assessing meaning and purpose in life
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
UCLA Loneliness Scale
Time Frame: from baseline to 2-year follow-up
|
20-item self-report scale assessing loneliness
|
from baseline to 2-year follow-up
|
|
Height, weight, waist measurement
Time Frame: from baseline to 2-year follow-up
|
Height, weight, waist measurement
|
from baseline to 2-year follow-up
|
|
Beery Visuomotor Integration, 6th edition
Time Frame: from baseline to 2-year follow-up
|
validated, rater-administered measure assessing visuo-motor integration
|
from baseline to 2-year follow-up
|
|
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.
|
from baseline to 2-year follow-up
|
|
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."
|
from baseline to 2-year follow-up
|
|
Finger tapping indices
Time Frame: from baseline to 2-year follow-up
|
Participants will perform a finger tapping task, while monitored on electroencephalogram (EEG)
|
from baseline to 2-year follow-up
|
|
Child Behavior Checklist
Time Frame: from baseline to 2-year follow-up
|
validated, 113-item, proxy-report questionnaire assessing psychopathology in children and adolescents
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
Toronto Obsessive-Compulsive Scale (TOCS)
Time Frame: from baseline to 2-year follow-up
|
validated, 21-item proxy-report questionnaire assessing OCD symptom severity
|
from baseline to 2-year follow-up
|
|
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
|
from basline to 2-year follow-up
|
|
BRIEF-2 Parent Form
Time Frame: from baseline to 2-year follow-up
|
validated, 63-item proxy-report questionnaire assessing executive dysfunction
|
from baseline to 2-year follow-up
|
|
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
|
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
|
8-item, proxy-report questionnaire assessing anxiety
|
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
|
8-item, proxy-report questionnaire assessing depression
|
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
|
7-item, proxy-report questionnaire assessing proxy-perceived peer relationship quality
|
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
|
4-item, proxy-report questionnaire assessing proxy-perceived family relationship quality
|
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
|
4-item, proxy-report questionnaire assessing proxy-perceived sleep disturbances
|
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
|
8-item, proxy-report questionnaire assessing proxy-perceived meaning and purpose in adolescent's life
|
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
|
8-item, proxy-report questionnaire assessing adolescent's satisfaction with life
|
from baseline to 2-year follow-up
|
|
Short Sensory Profile - 2
Time Frame: from baseline to 2-year follow-up
|
validated, 34-item proxy-report questionnaire assessing sensory experiences
|
from baseline to 2-year follow-up
|
|
Developmental Coordination Disorder Questionnaire
Time Frame: from baseline to 2-year follow-up
|
15-item proxy-report questionnaire assessing motor coordination
|
from baseline to 2-year follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
baseline
|
|
UCLA Loneliness Scale (Adult Proxy)
Time Frame: from baseline to 2-year follow-up
|
20-item self-report questionnaire assessing loneliness
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
|
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
|
from baseline to 2-year follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Isaacs, MD, MPH, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Neurodevelopmental Disorders
- Movement Disorders
- Heredodegenerative Disorders, Nervous System
- Basal Ganglia Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Tic Disorders
- Tourette Syndrome
- Behavior
Other Study ID Numbers
- 241465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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