Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neural Correlates of Sensory Phenomena in Tourette Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914664
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
David Isaacs, Vanderbilt University Medical Center

Brief Summary:
The primary aim of this study is to identify neural correlates of sensory phenomena in adults with Tourette syndrome (TS). Adult patients with TS will be recruited 1) to complete a standardized clinical symptom assessment battery and 2) to undergo monitoring with video-electroencephalogram (EEG) during tactile and auditory tasks, as well as in a resting state.

Condition or disease Intervention/treatment
Tourette Syndrome Sensory Disorders Hypersensitivity Tics Diagnostic Test: Electroencephalogram (EEG) testing procedure

Detailed Description:

Tourette syndrome (TS) is a neurodevelopmental disorder affecting 1% of school-aged children; one-third of patients suffer persistent tics into adulthood. Diagnostic criteria rely solely on motor symptoms, but sensory phenomena are a nearly universal feature, manifesting as 1) premonitory urges (PUs) and 2) sensory hypersensitivity. 1) Ninety percent of patients perceive unpleasant premonitory bodily urges preceding tic expression, and 60% find these more distressing than tics themselves. As PUs and tics are clinically paired, one would expect tight symptom severity correlation; however, published results are conflicting. Imaging studies reveal the likely role of a widespread sensory processing network in PU formation, but much ambiguity surrounds the precise neural substrates of PUs. 2) In addition to PUs, 80% of TS patients report heightened awareness of internal and external stimuli. Scant research has been devoted to this aspect of TS, but one small series found this sensory hypersensitivity to be independent of both PU and tic severity, delineating it as a distinct facet of the syndrome. Despite their ubiquity and detrimental impact on quality of life, sensory phenomena in TS remain poorly understood: the clinical relationship with tics is unclear, the pathophysiologic mechanisms are imprecisely characterized, and the treatment is non-existent. Network oscillations, captured in real-time with EEG, are a promising means of addressing this crucial knowledge gap.

Part 1. Clinical Variables and Scales - Adult TS patients will be recruited to complete a battery of validated clinical scales, providing a comprehensive phenotype. The scales include the following: Yale Global Tic Severity Scale (YGTSS); Dimensional Obsessive-Compulsive Scale (DOCS); Adult ADHD Self-Report Screening Scale for DSM-V; Generalized Anxiety Disorder 7 (GAD-7); Patient Health Questionnaire 9 (PHQ-9); Premonitory Urge to Tic Scale (PUTS); Sensory Gating Inventory (SGI); Sensory Perception Quotient (SPQ); and GTS-Quality of Life (GTS-QOL) Rating Scale. Patients with previously diagnosed 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. Patients with obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), anxiety, and/or depression will be permitted, given that these diagnoses are widely prevalent in the adult TS population. Age-matched, healthy-controls (HCs) will be recruited to complete the mood and sensory instruments. All study procedures will be completed during a single testing session. Medical and neurologic history, family history, substance use history, developmental history, and current and past psychotropic pharmacotherapies, will be reviewed.

Part 2. EEG Testing - Each participant will undergo a single-session EEG paradigm consisting of somatosensory and auditory event-related potentials (ERP), as well as a resting state condition. The somatosensory stimulus consists of a non-painful stimulus to the arm, and the auditory stimulus consists of a non-painful sound delivered through headphones. The entire recording session will take approximately 1-1.5 hours. Participants will be video-recorded, to allow for subsequent identification of tics.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neural Correlates of Sensory Phenomena in Tourette Syndrome
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tourette Syndrome
Adults (>18 years of age) with diagnosis of Tourette syndrome
Diagnostic Test: Electroencephalogram (EEG) testing procedure
EEG testing procedure, comprised of somatosensory and auditory event-related potential paradigms, as well as resting state EEG

Healthy Control
Adults who are generally healthy with no known neurologic or psychiatric diagnoses
Diagnostic Test: Electroencephalogram (EEG) testing procedure
EEG testing procedure, comprised of somatosensory and auditory event-related potential paradigms, as well as resting state EEG




Primary Outcome Measures :
  1. Network Oscillations in the Gamma (>30 Hz) Frequency Range [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Premonitory Urge to Tic Scale (PUTS) [ Time Frame: Within 1 month of baseline ]
    Validated self-report questionnaire comprised of 9 items assessing character and severity of premonitory urges. Scale range: 9 (least affected) - 36 (most affected)

  2. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Within 1 month of baseline ]
    Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)

  3. Dimensional Obsessive Compulsive Scale (DOCS) [ Time Frame: Within 1 month of baseline ]
    Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)

  4. Adult ADHD Self-Report Screening Scale [ Time Frame: Within 1 month of baseline ]
    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)

  5. Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: Within 1 month of baseline ]
    Validated self-report scale assessing presence and extent of anxiety, comprised of 7 items. Scale range 0 (least affected) - 21 (most affected)

  6. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Within 1 month of baseline ]
    Validated self-report scale assessing presence and extent of depression, comprised of 9 items. Scale range 0 (least affected) - 27 (most affected)

  7. Sensory Gating Inventory (SGI) [ Time Frame: Within 1 month of baseline ]
    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)

  8. Sensory Perception Quotient (SPQ) [ Time Frame: Within 1 month of baseline ]
    Validated self-report questionnaire assessing sensory hypo- or hyper-sensitivity, comprised of 35 items. Scale range 0 (highest sensory sensitivity) - 105 (lowest sensory sensitivity).

  9. Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) [ Time Frame: Within 1 month of baseline ]
    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)

  10. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment [ Time Frame: Within 1 month of baseline ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The two groups of participants will include 1) patients with Tourette syndrome and 2) healthy controls.
Criteria

Inclusion Criteria:

  • Diagnosis of Tourette syndrome
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • Prior diagnosis of autism spectrum disorder, developmental delay, cerebral palsy, other significant neurologic disease, schizophrenia, or psychotic disorders
  • Previously diagnosed hearing or tactile impairment
  • Current use of benzodiazepines (e.g. Clonazepam, Diazepam, Alprazolam) or anti-seizure medications (e.g. Topiramate, Lamotrigine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914664


Contacts
Layout table for location contacts
Contact: David A Isaacs, MD 6159362025 david.a.isaacs@vumc.org
Contact: Chelsea Mundy 6159362025 chelsea.e.mundy@vumc.org

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-5400
Contact: Chelsea Mundy    615-936-2025    chelsea.e.mundy@vumc.org   
Principal Investigator: David A Isaacs, MD         
Sub-Investigator: Heather Riordan, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Layout table for additonal information
Responsible Party: David Isaacs, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03914664    
Other Study ID Numbers: NCoSPTS
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified clinical variables and EEG data metrics may be shared with other researchers. This has yet to be finally determined.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tourette Syndrome
Sensation Disorders
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Immune System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations