Tic Suppression Task for Tourette Syndrome
(NS in TS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores treatments for Tourette syndrome (TS), a condition characterized by involuntary movements and sounds called tics. Researchers aim to understand the impact of hormones (chemical messengers) on TS, particularly why it is more common in boys and how stress influences it. The trial will test a new approach using neuroactive steroids (a type of hormone therapy) and tasks designed to help suppress tics. Children aged 8 to 12 with TS who meet specific developmental criteria related to puberty may be suitable candidates for this study.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatments for TS.
Will I have to stop taking my current medications?
The trial requires that participants stop taking medications that can change stress sensitivity, like antidepressants and anxiolytics (medications for anxiety). If you're on these medications, you may need to stop them to join the trial.
What prior data suggests that the tic suppression task is safe for children with tics?
Research shows that children with Tourette syndrome can sometimes suppress their tics in controlled settings. In one study, most children who managed this felt a stronger urge to tic during the task. This suggests that while tic suppression is possible, it can be challenging for some children.
Specific safety data on tic suppression is lacking, but this method avoids medications or surgeries, typically implying fewer risks. The trial examines the use of neuroactive steroids and tic suppression tasks. Since these steroids are not yet approved for Tourette syndrome, safety information may be limited. However, this type of study usually focuses on observing and understanding behavior, which generally poses less risk than drug trials.
Prospective participants should consult with researchers or their doctor. They can provide more details on what to expect and assist in making an informed decision.12345Why are researchers excited about this trial?
Researchers are excited about the Tic Suppression Task for Tourette Syndrome because it explores a unique approach that combines neuroactive steroids with a behavioral technique. Unlike typical treatments, which often rely on medications like antipsychotics or alpha-2 adrenergic agonists to manage symptoms, this method focuses on a behavioral paradigm that encourages children to consciously suppress their tics. This could provide a drug-free or reduced-drug option, potentially minimizing side effects. Additionally, neuroactive steroids are being investigated for their ability to modulate brain activity in a way that could support tic suppression, offering a novel mechanism of action compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for Tourette syndrome?
Research has shown that attempting to hold back tics can help people with Tourette syndrome manage them more effectively. In this trial, participants will engage in a tic suppression task to assess its effectiveness. Studies have found that when children with tic disorders are encouraged to suppress their tics, especially with rewards, their tics can become less severe. The Yale Global Tic Severity Scale, which measures tic severity, has tracked these improvements. This suggests that learning to control tics, even briefly, might help reduce their impact over time. While this method appears promising, it often works better when combined with other treatments.15678
Who Is on the Research Team?
Marco Bortolato, MD PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tic Suppression Experimental Paradigm
Children with tics will undergo a tic suppression experimental paradigm to study the dynamic alterations in steroidomic salivary profiles
Follow-up
Participants are monitored for changes in salivary allopregnanolone concentrations and tic frequency
What Are the Treatments Tested in This Trial?
Interventions
- Neuroactive Steroids
- Tic suppression task
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
University of Miami
Collaborator
Albert Einstein College of Medicine
Collaborator