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Completed

NCT Number: NCT03508245

Investigating Circadian Rhythms in Youth With Persistent Tic Disorders

This study examines circadian rhythms and morningness-eveningness preference in youth with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD); and assesses the effects of wearable short wavelength light therapy on circadian rhythms and tic symptoms.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Wearable short wavelength light therapy

Other

Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks

Other names: Re-Timer

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2018
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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