Neural Correlates of Sensory Phenomena in Tourette Syndrome

NCT03914664 | Enrolling By Invitation

• 1 other identifier: NCoSPTS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tourette Syndrome; Sensory Disorders; Hypersensitivity; Tics

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• Heart rate variability

  Change beat-to-beat variability in heart rate

  Baseline

• Electrodermal activity in response to sensory stimuli

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

  Baseline

Secondary Outcomes (12)

• Premonitory Urge to Tic Scale (PUTS)

  Within 1 week of baseline

• Yale Global Tic Severity Scale (YGTSS)

  Within 1 week of baseline

• Dimensional Obsessive Compulsive Scale (DOCS)

  Within 1 week of baseline

• Adult ADHD Self-Report Screening Scale

  Within 1 week of baseline

• Generalized Anxiety Disorder 7 (GAD-7)

  Within 1 week of baseline

Study Arms (2)

Tourette Syndrome

Adults (\>18 years of age) with diagnosis of Tourette syndrome

Diagnostic Test: Electroencephalogram (EEG) testing procedure; Diagnostic Test: Autonomic function testing procedure

Healthy Control

Adults who are generally healthy with no known neurologic or psychiatric diagnoses

Diagnostic Test: Electroencephalogram (EEG) testing procedure; Diagnostic Test: Autonomic function testing procedure

Interventions

Electroencephalogram (EEG) testing procedure DIAGNOSTIC_TEST

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

Healthy Control; Tourette Syndrome

Autonomic function testing procedure DIAGNOSTIC_TEST

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

Healthy Control; Tourette Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• \- 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
• ≥ 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)
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5400, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Sensation Disorders; Hypersensitivity; Tics

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Dyskinesias

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: July 20, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The above information will be available for sharing within 6 months of publication.
• Access Criteria: Researchers wishing to access the above information should contact the investigative team and provide: 1) hypothesis-driven scientific question for which the data will be analyzed and 2) proposed methods for responsibly analyzing the data.

Locations

US (1)