What side effects are associated with this type of intervention?

Common treatments for Tourette Syndrome include antipsychotic medications, which can cause side effects such as weight gain, sedation, and metabolic changes. Alpha-2 adrenergic agonists like clonidine and guanfacine may lead to drowsiness, fatigue, and hypotension. Behavioral therapies are generally well-tolerated but may require significant time and effort. The trial on steroid profiling may involve corticosteroids, which can have side effects such as hyperglycemia, increased infection risk, bone loss, and neuropsychiatric effects. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the individual needs of the patient.

What prior FDA approvals exist?

FDA-approved treatments for Tourette Syndrome primarily include antipsychotic medications such as haloperidol and pimozide, as well as alpha-2 adrenergic agonists like clonidine and guanfacine. These treatments help manage tics and associated symptoms. While the context does not provide specific information on steroid-related treatments, ongoing research is exploring the role of neuroactive steroids in Tourette Syndrome, aiming to identify novel biomarkers and therapeutic targets that could potentially lead to new treatment options.

What other types of research exist?

Promising novel alternatives to steroid profiling for Tourette Syndrome patients include: 1) Genetic therapies targeting specific mutations associated with TS, 2) Deep brain stimulation (DBS) for severe cases, 3) Neuroactive steroid modulation, and 4) Behavioral and cognitive therapies enhanced by digital health technologies. These approaches are based on recent advancements and ongoing research in the field.

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Tic Suppression Task for Tourette Syndrome (NS in TS Trial)

N/A

Waitlist Available

Led By Marco Bortolato, MD PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Clinically significant endocrinological disorders

Other neurological disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying certain brain-affecting chemicals in boys and girls with Tourette syndrome to understand why it's more common in males and how stress impacts symptoms. The goal is to see if changing these chemical levels can help control tics.

Who is the study for?

This trial is for boys and girls aged 8-12 with Tourette Syndrome (TS), who can perform a tic suppression task. Participants must meet the diagnostic criteria for TS, have no other tic disorders if they are controls, and be at a certain stage of puberty. Those with major psychiatric or neurological disorders, endocrine issues, or on hormone-altering drugs cannot join.

What is being tested?

The study aims to understand why more males have TS and why stress affects it by looking at steroid levels in affected children. It will involve performing a tic suppression task to see how steroids might influence tics.

What are the potential side effects?

Since this trial involves observational tasks rather than medication administration, there are no direct side effects from interventions like drugs; however, participants may experience stress or discomfort during the tasks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious hormone-related disorder.

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I have a neurological disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Salivary allopregnanolone concentrations

Secondary study objectives

Tic frequency

Other study objectives

Measurement of salivary concentrations of other neuroactive steroids

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: Tic suppressionExperimental Treatment1 Intervention

Children with tics will undergo a tic suppression experimental paradigm.

0 / 2Eligibility criteria met

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

The most common treatments for Tourette Syndrome (TS) often involve neuroactive steroids, which modulate neurotransmitter systems such as GABAergic and glutamatergic pathways. These pathways are crucial in regulating the motor and phonic tics characteristic of TS. By understanding and targeting these mechanisms, researchers aim to identify novel biomarkers and develop more precise therapies, potentially improving symptom management and reducing side effects for TS patients.