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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:
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I have a serious hormone-related disorder.
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I have a neurological disorder.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,696,822 Total Patients Enrolled
6 Trials studying Tourette Syndrome
372 Patients Enrolled for Tourette Syndrome
University of MiamiOTHER
949 Previous Clinical Trials
428,337 Total Patients Enrolled
Albert Einstein College of MedicineOTHER
296 Previous Clinical Trials
11,688,777 Total Patients Enrolled

Media Library

Tic suppression task Clinical Trial Eligibility Overview. Trial Name: NCT05281445 — N/A
Tourette Syndrome Research Study Groups: Tic suppression
Tourette Syndrome Clinical Trial 2023: Tic suppression task Highlights & Side Effects. Trial Name: NCT05281445 — N/A
Tic suppression task 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281445 — N/A
~33 spots leftby Dec 2025