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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Emily J. Ricketts, PhD, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Tourette's Disorder Other: Wearable short wavelength light therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

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


Contacts
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Contact: Emily Ricketts, PhD (310) 825-2701 ERicketts@mednet.ucla.edu

Locations
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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    cmshim@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Emily J Ricketts, PhD University of California, Los Angeles

Publications:
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.
Guy W. ECDEU assessment manual for psychopharmacology. Rev. Rockville, Md.: National Institute of Mental Health. (DHEW publication no. (ADM) 76-338), 1976.
Niederhofer H. Bright light therapy may be a therapeutic option for Tourette's syndrome. Acta Neuropsychologica 7(4): 283-285, 2009.

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Responsible Party: Emily J. Ricketts, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03508245    
Other Study ID Numbers: 17-000869
K23MH113884-01 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily J. Ricketts, PhD, University of California, Los Angeles:
Tourette Syndrome
Tourette's
Tics
Circadian
Sleep
Additional relevant MeSH terms:
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Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn