Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
Primary Purpose
Tourette's Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable short wavelength light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Tourette's Disorder focused on measuring Tourette Syndrome, Tourette's, Tics, Circadian, Sleep
Eligibility Criteria
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
Sites / Locations
- Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Wearable short wavelength light therapy
Arm Description
Wearable short wavelength light therapy
Outcomes
Primary Outcome Measures
Dim Light Melatonin Onset
The clock time at which salivary melatonin concentration reaches a threshold of 4 picograms (pg) per milliliter.
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).
Secondary Outcome Measures
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.
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).
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.
Full Information
NCT ID
NCT03508245
First Posted
April 16, 2018
Last Updated
August 10, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03508245
Brief Title
Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
Official Title
Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Disorder
Keywords
Tourette Syndrome, Tourette's, Tics, Circadian, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearable short wavelength light therapy
Arm Type
Other
Arm Description
Wearable short wavelength light therapy
Intervention Type
Other
Intervention Name(s)
Wearable short wavelength light therapy
Other Intervention Name(s)
Re-Timer
Intervention Description
Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
Primary Outcome Measure Information:
Title
Dim Light Melatonin Onset
Description
The clock time at which salivary melatonin concentration reaches a threshold of 4 picograms (pg) per milliliter.
Time Frame
2 weeks
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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 Outcome Measure Information:
Title
Clinical Global Impression-Improvement (CGI-I) Scale
Description
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
Title
Children's Morningness-Eveningness Preferences Scale (CMEP)
Description
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
Title
Parent Tic Questionnaire (PTQ)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Ricketts, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8506460
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25571772
Citation
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.
Results Reference
background
Citation
Guy W. ECDEU assessment manual for psychopharmacology. Rev. Rockville, Md.: National Institute of Mental Health. (DHEW publication no. (ADM) 76-338), 1976.
Results Reference
background
PubMed Identifier
2768151
Citation
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.
Results Reference
background
Citation
Niederhofer H. Bright light therapy may be a therapeutic option for Tourette's syndrome. Acta Neuropsychologica 7(4): 283-285, 2009.
Results Reference
background
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Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
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