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Tourette SyndromeNCT03914664

Neural Correlates of Sensory Phenomena in Tourette Syndrome

An observational study of Tourette Syndrome and Sensory Disorders, run by Vanderbilt University Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The most pervasive sensory manifestation of TS is sensory over-responsivity (SOR). SOR is defined as excessive behavioral response to commonplace environmental stimuli. SOR is an integral but poorly understood facet of the TS phenotype, one intertwined with core elements of the disorder and worse QOL. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Electroencephalogram (EEG) testing procedure and Autonomic function testing procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
20 Jul 2021to 28 Feb 2027
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The two groups of participants will include: 1. adult with Tourette syndrome or other chronic tic disorder 2. healthy controls

Who may be able to join

  • Diagnosis of Tourette syndrome or other chronic tic disorder
  • ≥ 18 years of age
  • Ability to complete survey instruments
  • English fluency (given that all scales are validated in English)
  • ≥ 18 years of age AND age within 5 years of a participant in the TS arm of same biological sex (for purposes of age- and sex-matching)
  • Ability to complete survey instruments
  • English fluency (given that all scales are validated in English)

Who cannot join

  • Known diagnosis of autism spectrum disorder, developmental delay, cerebral palsy, other significant neurologic disease, schizophrenia, or psychotic disorders will be excluded, in order to lessen potentially confounding factors.
  • (Note: Patients with OCD, ADHD, anxiety, and/or depression will be permitted, given that these diagnoses are widely prevalent in the adult TS population.)
  • Use of anti-seizure medications, stimulants, or other psychotropic medications known to alter EEG signal
  • Recreational substance use within past 30 days
  • Any neurologic or psychiatric diagnoses
  • History of tics
  • Use of any psychotropic medications within the past 30 days
  • Recreational substance use within past 30 days

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5400

Other trials in United States

About this study

The most pervasive sensory manifestation of TS is sensory over-responsivity (SOR). SOR is defined as excessive behavioral response to commonplace environmental stimuli. SOR is an integral but poorly understood facet of the TS phenotype, one intertwined with core elements of the disorder and worse QOL. This proposal seeks to clarify the mechanistic bases of SOR in TS. Adults with with TS will be recruited 1) to complete a standardized clinical symptom assessment battery and 2) to undergo electroencephalogram (EEG), autonomic, and audio-visual monitoring during tactile and auditory stimuli paradigms, as well as at rest.

Read the detailed description

Tourette syndrome (TS) is a multifaceted disorder that affects 0.6-1% of the global population. Across the lifespan, individuals with TS suffer worse quality of life (QOL) than the general population. While tics are the defining feature of TS, it is the widespread psychiatric and sensory symptoms that exert greater impact on QOL: more than 85% of individuals with TS are diagnosed with a psychiatric disorder, and 90% experience distressing sensory symptoms. The latest TS disease models and practice guidelines account for common psychiatric symptoms, but sensory symptoms remain under-recognized and under-studied. Progress in understanding and treating TS requires deepening insight into the disorder's sensory dimension.

The most pervasive sensory manifestation of TS is sensory over-responsivity (SOR). SOR is defined as excessive behavioral response to commonplace environmental stimuli. SOR is associated with avoidant behavior and functional impairment. More than 50% of children and 80% of adults with TS report SOR. Across age groups, SOR is positively correlated with severity of tics and psychiatric symptoms and negatively correlated with QOL. Thus, SOR is an integral facet of the TS phenotype, one intertwined with core elements of the disorder and worse QOL. This proposal seeks to clarify the mechanistic bases of SOR in TS (Aims 1 and 2).

Enhanced understanding of SOR's neurobiological basis is crucial to a more complete knowledge of TS pathophysiology. Two neurophysiologic mechanisms are implicated in SOR: sensory gating impairment and autonomic hyperarousal. Sensory gating is the physiologic process whereby redundant environmental stimuli are filtered out in the early stages of perception. Impairment of sensory gating gives rise to altered sensory perception. Autonomic hyperarousal is a state of excessive sympathetic tone and/or reduced parasympathetic tone, which hampers behavioral adaptation to sensory input. In TS, multiple lines of evidence suggest both sensory gating and autonomic function are impaired. However, prior investigations have suffered from methodologic limitations and have not examined the link between neurophysiologic dysfunction and sensory symptoms.

Aim 1. Identify an electroencephalographic (EEG) signature of SOR in TS. Hypotheses: (1a) relative to healthy controls, TS adults exhibit impaired sensory gating; (1b) extent of impaired sensory gating in TS correlates with degree of SOR. We will recruit 60 TS adults and 60 age- and sex-matched healthy controls to complete rating scales for SOR, psychiatric symptoms, and tics. Subjects will then be monitored on dense-array scalp EEG during sequential auditory and tactile sensory gating paradigms.

Aim 2. Identify an autonomic signature of SOR in TS. Hypotheses: (2a) relative to healthy controls, TS adults exhibit autonomic hyperarousal in response to non-aversive sensory stimuli; (2b) extent of autonomic hyperarousal correlates with SOR severity in TS. Heart rate and electrodermal activity will be monitored during the Aim 1 sensory gating paradigms and during a 10-minute rest period. Heart rate variability and electrodermal activity will serve as indices of parasympathetic and sympathetic activity, respectively.

Impact: Results will clarify the extent of sensory gating impairment in TS, the nature of autonomic dysfunction in TS, and the clinical correlates of neurophysiologic dysfunction in TS.

Being tested
Electroencephalogram (EEG) testing procedure, Autonomic function testing procedure
Medical subject headings
Tourette Syndrome, Sensation Disorders, Hypersensitivity, Tics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroencephalogram (EEG) testing procedureDiagnostic test

    EEG testing procedure, comprised of somatosensory and auditory event-related potential paradigms, as well as resting state EEG

  • Autonomic function testing procedureDiagnostic test

    Autonomic function testing procedure, comprised of electrodes to determine heart rate variability and electrodermal activity (EDA)

Study groups in NCT03914664
Study groupRoleWhat they receive
Tourette SyndromeAdults (>18 years of age) with diagnosis of Tourette syndrome
Receives: Diagnostic Test: Electroencephalogram (EEG) testing procedure; Diagnostic Test: Autonomic function testing procedure
Healthy ControlAdults who are generally healthy with no known neurologic or psychiatric diagnoses
Receives: Diagnostic Test: Electroencephalogram (EEG) testing procedure; Diagnostic Test: Autonomic function testing procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Network oscillations in response to sensory stimuli

    Neural activity captured on EEG can be spectrally decomposed into various frequency constituencies. Neural activity in the gamma frequency range, so-called gamma band oscillations (GBOs), are associated with sensory processing and integration and are postulated to underlie sensory phenomena in TS.

    Measured: Baseline

  2. Heart rate variability

    Change beat-to-beat variability in heart rate

    Measured: Baseline

  3. Electrodermal activity in response to sensory stimuli

    Sweat response changes within 1-3 seconds of non-aversive sensory stimulus

    Measured: Baseline

Secondary outcomes (12)
  1. Premonitory Urge to Tic Scale (PUTS)

    Validated self-report questionnaire comprised of 9 items assessing character and severity of premonitory urges. Scale range: 9 (least affected) - 36 (most affected)

    Measured: Within 1 week of baseline

  2. Yale Global Tic Severity Scale (YGTSS)

    Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)

    Measured: Within 1 week of baseline

  3. Dimensional Obsessive Compulsive Scale (DOCS)

    Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)

    Measured: Within 1 week of baseline

  4. Adult ADHD Self-Report Screening Scale

    Validated self-report scale, developed since release of Diagnostic and Statistical Manual-V, comprised of 6 items. Scale range 0 (least affected) - 24 (most affected)

    Measured: Within 1 week of baseline

  5. Generalized Anxiety Disorder 7 (GAD-7)

    Validated self-report scale assessing presence and extent of anxiety, comprised of 7 items. Scale range 0 (least affected) - 21 (most affected)

    Measured: Within 1 week of baseline

  6. Patient Health Questionnaire 9 (PHQ-9)

    Validated self-report scale assessing presence and extent of depression, comprised of 9 items. Scale range 0 (least affected) - 27 (most affected)

    Measured: Within 1 week of baseline

  7. Sensory Gating Inventory (SGI)

    Validated self-report questionnaire assessing sensory hypo- or hyper-sensitivity, comprised of 36 items. The 4 sub-scales include Perceptual Modulation, Distractability, Over-Inclusion, and Fatigue and Stress Vulnerability. Total scale range 0 (least affected) - 180 (most affected)

    Measured: Within 1 week of baseline

  8. Sensory Perception Quotient (SPQ)

    Validated self-report questionnaire assessing sensory hypo- or hyper-sensitivity, comprised of 35 items. Scale range 0 (highest sensory sensitivity) - 105 (lowest sensory sensitivity).

    Measured: Within 1 week of baseline

  9. Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL)

    Validated self-report questionnaire assessing health-related quality of life for patients with Tourette syndrome, comprised of 27 items. Scale range 0 (best quality of life) - 108 (worst quality of life)

    Measured: Within 1 week of baseline

  10. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment

    Validated self-report questionnaire to measures sleep-related impairments, consisting of 8 items. Scale range 0 - 100 (t-score scaled with lower values indicating less impairment).

    Measured: Within 1 week of baseline

  11. Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2)

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 37 items. Each scale item is a statement to which respondents must select "never" (0) to "always" (5) on a six-point Likert scale. No total MAIA-2 score exists. Rather, individual scale items belong to one of eight MAIA-2 subscales. For each subscale, higher score signifies more of that construct.

    Measured: Within 1 week of baseline

  12. Body Perception Questionnaire - Short Form (BPQ-SF)

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 46 items total, divided into 3 sections: Body Awareness (raw total score 26-130), Supradiaphragmatic Reactivity (raw total score 15-69), and Subdiaphragmatic Reactivity (raw total score 6-28). Raw scores are converted to T-scores. Higher raw and T-scores indicate greater maladaptive body awareness.

    Measured: Within 1 week of baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start20 Jul 2021
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03914664
Sponsor's protocol ID
NCoSPTS
Status last verified
Jan 2026
First submitted
11 Apr 2019
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified clinical variables, EEG data, and autonomic data metrics may be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Tourette Syndrome and Sensory Disorders, 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 7 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Network oscillations in response to sensory stimuli (time frame: Baseline). The study lists 3 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 14 Jan 2026.

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