NCT06576726

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2024May 2030

First Submitted

Initial submission to the registry

August 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4.8 years

First QC Date

August 26, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

Tourette syndrometic disordersensorimotorsensorymotorsensory over-responsivitypsychosocialdevelopmentbehavioralneurophysiology

Outcome Measures

Primary Outcomes (9)

  • Adolescent/Adult Sensory Profile (AASP)

    validated, 60-item self-report questionnaire assessing sensory experiences

    from baseline to 2-year follow-up

  • Sensory Perception Quotient

    35-item self-report questionnaire assessing self-perceived basic sensory sensitivity

    from baseline to 2-year follow-up

  • Sensory Gating Inventory

    validated, 36-item self-report questionnaire assessing sensory over-responsivity

    from baseline to 2-year follow-up

  • Adolescent Motor Competence Questionnaire (AMCQ)

    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)

    validated, rater-administered scale assessing motor coordination

    from baseline to 2-year follow-up

  • Purdue pegboard

    validated, rater-administered task assessing manual dexterity and coordination

    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

    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.

    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

    from baseline to 2-year follow-up

Secondary Outcomes (33)

  • Yale Global Tic Severity Scale (YGTSS)

    from baseline to 2-year follow-up

  • Premonitory Urge for Tics Scale (PUTS)

    from baseline to 2-year follow-up

  • Adult ADHD Self-Report Scale for DSM-V (ASRS-V)

    from baseline to 2-year follow-up

  • Obsessive-Compulsive Inventory-Child Version-Revised (OCI-CV-R)

    from baseline to 2-year follow-up

  • PROMIS Pediatric SF GenPop v3.0 - Anxiety 8a

    from baseline to 2-year follow-up

  • +28 more secondary outcomes

Other Outcomes (8)

  • Edinburgh Handedness Inventory - Short Version

    from baseline to 2-year follow-up

  • Pubertal Development Scale

    from baseline to 2-year follow-up

  • Weschler Abbreviated Scale of Intelligence, 2nd edition (WASI-II), 2-subtest with Vocabulary and Matrix Reasoning

    baseline

  • +5 more other outcomes

Study Arms (2)

adolescents with tic disorder

Other: This study involves no intervention.

neurotypical adolescents (controls)

Other: This study involves no intervention.

Interventions

This study involves no intervention.

adolescents with tic disorderneurotypical adolescents (controls)

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants must be willing to attend Visits 2 and 4 in-person

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.
  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashvile, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Tourette SyndromeTic DisordersBehavior

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • David Isaacs, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Clinical Translational Research Coordinator II

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Pediatrics

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 29, 2024

Study Start

October 24, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

May 1, 2030

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations