跳至主要内容
临床试验/NCT03851484
NCT03851484招募中不适用

Sensory Symptoms in Tourette Syndrome

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2019年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
214
试验地点
2
主要终点
Baseline Sensory Perception Quotient score, short form

研究概览

简要总结

Patients with tics will be asked to complete a series of validated questionnaires (in electronic and/or paper format) regarding symptoms and conditions often associated with Tourette syndrome, including premonitory urges, sensory experiences, inattention, obsessive-compulsive tendencies, anxiety, and depression. Participants will also be asked to complete a quality of life assessment. This series of questionnaires will be administered annually.

详细描述

Patients with tics will be recruited to participate in an observational study assessing extent and variation in non-motor features of Tourette syndrome over time. Each participant will complete a battery of validated questionnaires and scales online or in paper format (per patient preference), including the Premonitory Urge to Tic Scale (PUTS), the Sensory Gating Inventory (SGI), the Sensory Perception Quotient, the ADHD Self-Report Screening Scale, and others. These questionnaires will be administered annually to patients. For the analysis, participants will be stratified by age into late adolescents (18-25 years old) and adults (older than 25 years) since adolescent development ends at approximately age 25.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Ability to provide informed consent and answer self-report questionnaires independently in English
  • Diagnosis of Tourette syndrome (TS), chronic motor tic disorder, or chronic vocal tic disorder

排除标准

  • History of psychotic disorder
  • History of significant neurologic disorder (e.g., stroke) other than TS or another chronic tic disorder

结局指标

主要结局

Baseline Sensory Perception Quotient score, short form

时间窗: Initial assessment at enrollment (time zero)

Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree 1. = agree 2. = disagree 3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.

Change in Sensory Perception Quotient score, short form at 2 years

时间窗: 2 years

Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree 1. = agree 2. = disagree 3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.

Change in Sensory Perception Quotient score, short form at 1 year

时间窗: 1 year

Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree 1. = agree 2. = disagree 3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.

次要结局

  • Baseline Premonitory Urge to Tic Scale score(Initial assessment at enrollment (time zero))
  • Change in Premonitory Urge to Tic Scale score at 2 years(2 years)
  • Change in Sensory Gating Inventory score at 1 year(1 year)
  • Baseline Sensory Gating Inventory score(Initial assessment at enrollment (time zero))
  • Change in Sensory Gating Inventory score at 2 years(2 years)
  • Change in Premonitory Urge to Tic Scale score at 1 year(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Isaacs

Associate Professor of Neurology

Vanderbilt University Medical Center

研究点 (2)

Loading locations...

相似试验