Investigating Circadian Rhythms in Youth With Persistent Tic Disorders

• ClinicalTrials.gov Identifier: NCT03508245
• Recruitment Status: Enrolling by invitation
• First Posted: April 25, 2018
• Last Update Posted: August 11, 2022
• Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Emily J. Ricketts, PhD, University of California, Los Angeles

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: N/A
• 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 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles

Los Angeles, California, United States, 90024

Sponsors and Collaborators

University of California, Los Angeles

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Emily J Ricketts, PhD; University of California, Los Angeles

More Information

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.

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.

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.

Niederhofer H. Bright light therapy may be a therapeutic option for Tourette's syndrome. Acta Neuropsychologica 7(4): 283-285, 2009.

• 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
• 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

Keywords provided by Emily J. Ricketts, PhD, University of California, Los Angeles:

Tourette Syndrome; Tourette's; Tics; Circadian; Sleep

Additional relevant MeSH terms:

Tic Disorders; Tics; Tourette Syndrome; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn