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CompletedNCT03508245Updated Dec 12, 2023

Investigating Circadian Rhythms in Youth With Persistent Tic Disorders

An interventional study of Wearable short wavelength light therapy in Tourette's Disorder, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Tourette's Disorder

Keywords

  • Tourette Syndrome
  • Tourette's
  • Tics
  • Circadian
  • Sleep
03

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. DSM-5 diagnosis of Tourette's Disorder, Persistent Motor Tic Disorder, or Persistent Vocal Tic Disorder
  2. Yale Global Tic Severity Scale Score ≥ 14 for Tourette's Disorder or ≥ 10 for Persistent Motor Tic Disorder or Persistent Vocal Tic Disorder
  3. fluency in English

Exclusion criteria

Exclusion Criteria:

  1. Current or lifetime diagnosis of Bipolar Disorder, psychosis, or autism spectrum disorder
  2. 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
  3. Current diagnosis of Obstructive Sleep Apnea, Restless leg syndrome, Periodic Limb Movement Disorder, or Narcolepsy
  4. Intellectual functioning below the low average range (WASI-II IQ score \< 80)
  5. Hypnotic medications, or melatonin within 8 weeks of study enrollment
  6. Changes in dosage of any psychiatric medications within the past month
  7. Behavior therapy for tics within the past 3 months
  8. Prior use of light therapy
  9. Current pregnancy or travel across > 2 time zones in the past month
  10. Medical or neurological condition (e.g., seizure disorder, migraines) that would interfere in the individual's ability to participate in the study
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    Wearable short wavelength light therapy

    Wearable short wavelength light therapy

    Other: Wearable short wavelength light therapy

Interventions

  • OtherWearable short wavelength light therapy

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

    Also known as: Re-Timer

05

What researchers measure

Primary outcomes

  1. Dim Light Melatonin Onset

    The clock time at which salivary melatonin concentration reaches a threshold of 4 picograms (pg) per milliliter.

    Time frame: 2 weeks

  2. Yale Global Tic Severity Scale (YGTSS)

    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).

    Time frame: 2 weeks

Secondary outcomes

  1. Clinical Global Impression-Improvement (CGI-I) Scale

    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.

    Time frame: 2 weeks

  2. Children's Morningness-Eveningness Preferences Scale (CMEP)

    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).

    Time frame: 2 weeks

  3. Parent Tic Questionnaire (PTQ)

    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.

    Time frame: 2 weeks

06

Study locations

1 site
  • Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
    Los Angeles, California 90095, United States
07

References and documents

Publications

  • Carskadon MA, Vieira C, Acebo C. Association between puberty and delayed phase preference. Sleep. 1993 Apr;16(3):258-62. doi: 10.1093/sleep/16.3.258. PubMed 8506460 ↗
  • Chang S, Himle MB, Tucker BTP, Woods DW. Initial psychometric properties of a brief-parent-report instrument for assessing tic severity in children with chronic tic disorders. Child and Family Behavior Therapy 31(3): 181-191, 2009.
  • Coles ME, Strauss GP. Shedding light on tics. Psychiatry Res. 2015 Feb 28;225(3):743. doi: 10.1016/j.psychres.2014.12.024. Epub 2014 Dec 23. No abstract available. PubMed 25571772 ↗
  • Guy W. ECDEU assessment manual for psychopharmacology. Rev. Rockville, Md.: National Institute of Mental Health. (DHEW publication no. (ADM) 76-338), 1976.
  • Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015. PubMed 2768151 ↗
  • Niederhofer H. Bright light therapy may be a therapeutic option for Tourette's syndrome. Acta Neuropsychologica 7(4): 283-285, 2009.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03508245
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Emily J. Ricketts, PhD (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
Apr 25, 2018
Start date
Jan 18, 2018
Primary completion
Jun 23, 2023
Completion
Jun 23, 2023
Last update
Dec 12, 2023

Study contacts

Emily J Ricketts, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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