What side effects are associated with this type of intervention?

Common treatments for Tourette Syndrome include behavioral therapies, such as Comprehensive Behavioral Intervention for Tics (CBIT), and medications like antipsychotics (e.g., risperidone, aripiprazole) and alpha-2 adrenergic agonists (e.g., clonidine, guanfacine). Behavioral therapies generally have minimal side effects, primarily related to the effort and time required for effective implementation. Antipsychotics can cause weight gain, sedation, and metabolic changes, while alpha-2 adrenergic agonists may lead to drowsiness, low blood pressure, and dry mouth. Non-pharmacologic treatments like the Forehead Temperature-Regulating Therapy being studied aim to improve sleep quality and may have fewer side effects, focusing on comfort and adherence.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Tourette Syndrome, including antipsychotics like haloperidol and pimozide, and alpha-2 adrenergic agonists such as clonidine and guanfacine. These medications primarily target the reduction of tics. While the Forehead Temperature-Regulating Therapy being studied focuses on improving sleep quality in individuals with Tourette Syndrome, there are no FDA-approved treatments specifically for sleep disturbances in this population. However, the use of behavioral and supportive therapies, including cognitive-behavioral therapy and sleep hygiene practices, is common in managing sleep issues associated with Tourette Syndrome.

What other types of research exist?

Promising novel alternatives to Forehead Temperature-Regulating Therapy for Tourette Syndrome patients include Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS). Both have shown potential in treating tic disorders and related symptoms.

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Behavioural Intervention

Temperature-Regulating Therapy for Insomnia in Tourette Syndrome

N/A

Recruiting

Led By Emily J Ricketts, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a forehead temperature-regulating device to help adults with Tourette's disorder sleep better. The device adjusts forehead temperature to improve brain function and sleep quality.

Who is the study for?

Adults aged 18-50 with Tourette's disorder and insomnia, who have a Yale Global Tic Severity Scale Score of at least 14 (or ≥10 for other tic disorders), sleep efficiency ≤85% on half or more nights, and an Insomnia Severity Index score >14. Excluded are those with bipolar disorder, psychosis, severe depression/anxiety within the last 6 months, high risk of sleep apnea, narcolepsy, irregular sleep schedules, Raynaud's disease or severe cold sensitivity.

What is being tested?

The trial is testing forehead temperature-regulating therapy over four weeks to see if it helps adults with Tourette's disorder improve their insomnia. It will also look into whether this treatment affects depression, anxiety levels during the day and severity of tics.

What are the potential side effects?

Potential side effects aren't specified but may include discomfort from wearing the device or skin irritation due to its temperature regulation feature.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Actigraphy - Sleep Onset Latency

Actigraphy - Wake After Sleep Onset

Secondary study objectives

Depression Anxiety Stress Scale (DASS)-21 - Anxiety

Depression Anxiety Stress Scale (DASS)-21 - Depression

Epworth Sleepiness Scale (ESS)

Other study objectives

Yale Global Tic Severity Scale (YGTSS) - Total Tic Severity Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Forehead Temperature-Regulating TherapyExperimental Treatment1 Intervention

Forehead Temperature-Regulating Therapy

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tourette Syndrome include stimulant medications, botulinum toxin therapy, and cognitive-behavioral therapy (CBT). Stimulant medications, such as methylphenidate, work by increasing dopamine levels in the brain, which can help improve attention and reduce hyperactivity without worsening tics. Botulinum toxin therapy involves injecting botulinum toxin into specific muscles to reduce the severity of motor tics by blocking nerve signals that cause muscle contractions. CBT helps patients manage the psychological aspects of Tourette Syndrome by teaching coping strategies and reducing stress, which can exacerbate tics. The Forehead Temperature-Regulating Therapy being studied aims to improve sleep quality, which is crucial for Tourette Syndrome patients as poor sleep can worsen tic severity and overall quality of life.