Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
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|ClinicalTrials.gov Identifier: NCT03508245|
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2018
Last Update Posted : August 11, 2022
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|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 2023|
|Estimated Study Completion Date :||August 2023|
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.
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|Ages Eligible for Study:||13 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- DSM-5 diagnosis of Tourette's Disorder, Persistent Motor Tic Disorder, or Persistent Vocal Tic Disorder
- Yale Global Tic Severity Scale Score ≥ 14 for Tourette's Disorder or ≥ 10 for Persistent Motor Tic Disorder or Persistent Vocal Tic Disorder
- fluency in English
- Current or lifetime diagnosis of Bipolar Disorder, psychosis, or autism spectrum disorder
- Suicidality, severe depression or anxiety (i.e., Depression or anxiety diagnosis is more severe than Tourette's Disorder; equivalence in severity is allowed), or substance dependence, present within the past 6 months
- Current diagnosis of Obstructive Sleep Apnea, Restless leg syndrome, Periodic Limb Movement Disorder, or Narcolepsy
- Intellectual functioning below the low average range (WASI-II IQ score < 80)
- Hypnotic medications, or melatonin within 8 weeks of study enrollment
- Changes in dosage of any psychiatric medications within the past month
- Behavior therapy for tics within the past 3 months
- Prior use of light therapy
- Current pregnancy or travel across > 2 time zones in the past month
- Medical or neurological condition (e.g., seizure disorder, migraines) that would interfere in the individual's ability to participate in the study
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
|United States, California|
|Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Emily J Ricketts, PhD||University of California, Los Angeles|
|Responsible Party:||Emily J. Ricketts, PhD, Principal Investigator, University of California, Los Angeles|
|Other Study ID Numbers:||
K23MH113884-01 ( U.S. NIH Grant/Contract )
|First Posted:||April 25, 2018 Key Record Dates|
|Last Update Posted:||August 11, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
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Genetic Diseases, Inborn