Forehead Temperature-Regulating Therapy for Tourette's Disorder (TD)
Phase-Based Progress Estimates
Effectiveness
Safety
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, Los Angeles, CA
Tourette's Disorder (TD)+3 More
Forehead Temperature-Regulating Therapy - DeviceEligibility
18 - 65
All Sexes
What conditions do you have?
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Eligibility
18 - 65
All Sexes
What conditions do you have?
Select
Study Summary
The primary aim of the present research project is to investigate the preliminary effects of four weeks of forehead temperature-regulating therapy on insomnia in adults with Tourette's disorder and co-occurring insomnia disorder. This project will also examine the effects of the device on depression, anxiety, and daytime sleepiness, and explore its effects on tic severity.
Eligible Conditions
- Tourette's Disorder (TD)
- Insomnia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 5 weeks
5 weeks
Actigraphy - Sleep Onset Latency
Actigraphy - Wake After Sleep Onset
Depression Anxiety Stress Scale (DASS)-21 - Anxiety
Depression Anxiety Stress Scale (DASS)-21 - Depression
Epworth Sleepiness Scale (ESS)
Yale Global Tic Severity Scale (YGTSS) - Total Tic Severity Score
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Forehead Temperature-Regulating Therapy
1 of 1
Experimental Treatment
25 Total Participants · 1 Treatment Group
Primary Treatment: Forehead Temperature-Regulating Therapy · No Placebo Group · N/A
Forehead Temperature-Regulating Therapy
Device
Experimental Group · 1 Intervention: Forehead Temperature-Regulating Therapy · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 weeks
Trial Background
Prof. Emily J. Ricketts, PhD
Principal Investigator
University of California, Los Angeles
Closest Location: Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles · Los Angeles, CA
N/AFirst Recorded Clinical Trial
2 TrialsResearching Tourette's Disorder (TD)
0 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have Tourette's disorder.
You have a sleep efficiency of less than 85 per cent on at least 50 per cent of nights over a week.
You are fluent in English.\n
You have a diagnosis of insomnia disorder.
You have Tourette's disorder or persistent motor tic disorder or persistent vocal tic disorder.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Johns, Murray W.. 1991. “A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/14.6.540.
- LECKMAN, JAMES F., MARK A. RIDDLE, MAUREEN T. HARDIN, SHARON I. ORT, KAREN L. SWARTZ, JOHN STEVENSON, and DONALD J. COHEN. 1989. “The Yale Global Tic Severity Scale: Initial Testing of a Clinician-rated Scale of Tic Severity”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1097/00004583-198907000-00015.
- Lovibond, P.F., and S.H. Lovibond. 1995. “The Structure of Negative Emotional States: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/0005-7967(94)00075-u.
- Emily J. Ricketts, PhD 2022. "Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499741.
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