Tourette Syndrome Clinical Trial
Official title:
Neural Correlates of Sensory Phenomena in Tourette Syndrome
NCT number | NCT03914664 |
Other study ID # | NCoSPTS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 20, 2021 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria for TS arm: - 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) Exclusion criteria for TS arm: - 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 Inclusion criteria for healthy control arm: - = 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) Exclusion criteria for healthy control arm: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Heart rate variability | Change beat-to-beat variability in heart rate | Baseline | |
Primary | Electrodermal activity in response to sensory stimuli | Sweat response changes within 1-3 seconds of non-aversive sensory stimulus | Baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | Yale Global Tic Severity Scale (YGTSS) | Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst) | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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). | Within 1 week of baseline | |
Secondary | 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) | Within 1 week of baseline | |
Secondary | 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). | Within 1 week of baseline | |
Secondary | 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. | Within 1 week of baseline | |
Secondary | 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. | Within 1 week of baseline |
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