Investigating Circadian Rhythms in Youth With Persistent Tic Disorders

NCT03508245 | Completed

• 2 other identifiers: 17-000869K23MH113884-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette's Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Dim Light Melatonin Onset

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

  2 weeks

• 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).

  2 weeks

Secondary Outcomes (3)

• Clinical Global Impression-Improvement (CGI-I) Scale

  2 weeks

• Children's Morningness-Eveningness Preferences Scale (CMEP)

  2 weeks

• Parent Tic Questionnaire (PTQ)

  2 weeks

Study Arms (1)

Wearable short wavelength light therapy

OTHER

Wearable short wavelength light therapy

Other: Wearable short wavelength light therapy

Interventions

Wearable short wavelength light therapy OTHER

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

Also known as: Re-Timer

Wearable short wavelength light therapy

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

Los Angeles, California, 90095, United States

Location

Related Publications (6)

• 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.

  PMID: 8506460 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25571772 BACKGROUND

• Guy W. ECDEU assessment manual for psychopharmacology. Rev. Rockville, Md.: National Institute of Mental Health. (DHEW publication no. (ADM) 76-338), 1976.

  BACKGROUND

• 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.

  PMID: 2768151 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily J Ricketts, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: January 18, 2018
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)