Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
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|ClinicalTrials.gov Identifier: NCT03508245|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Disorder||Other: Wearable short wavelength light therapy||Not Applicable|
Many individuals with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD) fail to significantly benefit from existing tic treatments. Case studies have shown morning exposure to light therapy, known to advance circadian phase is associated with modest to large tic reductions (Coles & Strauss, 2013; Niederhofer, 2003) suggesting the presence of circadian abnormalities (i.e., phase delay) in select individuals with PTDs. The present project assesses circadian phase and morningness-eveningness preference in youth with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD), and examines whether morning use of wearable short wavelength light therapy is associated with shifts in circadian rhythms and reductions in tic severity.
Study participation will take place over a three-week period. Clinician-rated tic interview and rating scales of morningness-eveningness preference, sleep, tic, and other symptoms will be completed during an initial screening assessment. Participants will then monitor sleep at home using an actigraph for one week and return for a baseline clinical assessment of tic severity and evening assessment of internal melatonin levels involving saliva sampling every 30 minutes for 6.5 hours in a dimly lit room. Next, participants will complete an abbreviated course (i.e., two weeks) of morning light therapy using wearable short wavelength (i.e., blue-green) light-emitting glasses while continuing to monitor sleep using the actigraph. Following this two-week period participants will return for a final assessment of tic severity and internal melatonin levels.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating Circadian Rhythms in Youth With Persistent Tic Disorders|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Wearable short wavelength light therapy
Wearable short wavelength light therapy
Other: Wearable short wavelength light therapy
Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
Other Name: Re-Timer
- Dim Light Melatonin Onset [ Time Frame: 2 weeks ]The clock time at which salivary melatonin concentration reaches a threshold of 4 picograms (pg) per milliliter.
- Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 2 weeks ]The YGTSS (Leckman et al., 1989) is a clinician-administered measure of tic severity encompassing tic number, frequency, intensity, complexity, and interference. The measure yields independent severity ratings for motor and vocal tics, a combined total tic severity score (0 to 50), and an independent tic-related impairment score (0 to 50).
- Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: 2 weeks ]The CGI-I (Guy, 1976) is a clinician-rated scale that has been used in a number of clinical trials for over 25 years, and in several studies with TD patients. The CGI-I is a clinician-rated measure of global patient improvement relative to baseline based on the clinician's perspective. Scores of Much (2) or Very Much (1) Improved indicate positive treatment response.
- Children's Morningness-Eveningness Preferences Scale (CMEP) [ Time Frame: 2 weeks ]The CMEP (Carskadon et al., 1993) is a 10-item measure of diurnal or nocturnal activity preference in recent past weeks. It will be modified to assess symptoms in the past week for the present study. The measure yields a total score ranging from 10 (extreme evening preference) to 42 (extreme morning preference).
- Parent Tic Questionnaire (PTQ) [ Time Frame: 2 weeks ]The PTQ (Chang et al., 2008) is a parent-reported measure of tic severity assessing both motor and vocal tics present within the past week. Individual tics are rated separately according to frequency and intensity. The measure yields separate scores for motor and vocal tics, in addition to a combined total tic severity score.
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): NCT03508245
|Contact: Emily Ricketts, PhD||(310) 825-2701||ERicketts@mednet.ucla.edu|
|United States, California|
|Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Christine Shim, BA 310-237-8431 email@example.com|
|Principal Investigator:||Emily J Ricketts, PhD||University of California, Los Angeles|