Tic Suppression Task for Tourette Syndrome

(NS in TS Trial)

Overseen By Marco Bortolato, MD PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Antidepressants, Anxiolytics

Disqualifiers: Psychotic disorder, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Neuroactive Steroids for treating Tourette Syndrome?

Research suggests that isoallopregnanolone, a type of neuroactive steroid, can reduce tic-like behaviors in a mouse model of Tourette Syndrome. This effect is similar to that of established treatments like haloperidol, indicating potential therapeutic benefits for Tourette Syndrome. ^{1 2 3 4 5}

Is the tic suppression task treatment safe for humans?

Research on neuroactive steroids like isoallopregnanolone suggests they are well-tolerated and have a good safety profile in animal models, indicating potential safety in humans. ^{3 4 6 7 8}

How does the tic suppression task treatment differ from other treatments for Tourette Syndrome?

The tic suppression task treatment is unique because it focuses on the ability to consciously suppress tics, which may help reduce tic frequency without the rebound effect often seen after suppression efforts. This approach is different from drug treatments that target neurochemical pathways, such as those involving the neurosteroid allopregnanolone, which can exacerbate tics under stress. ^{2 3 4 6 9}

What is the purpose of this trial?

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.

Research Team

Marco Bortolato, MD PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

I am between 8 and 12 years old.

Diagnostic criteria of TS for cases (and lack of any tic disorders for controls)

My sexual development stage has been confirmed.

Exclusion Criteria

I am not taking medications that affect stress sensitivity, like antidepressants or anxiolytics.

I have a serious hormone-related disorder.

I am using treatments that can change my hormone levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tic Suppression Experimental Paradigm

Children with tics will undergo a tic suppression experimental paradigm to study the dynamic alterations in steroidomic salivary profiles

2 years

Follow-up

Participants are monitored for changes in salivary allopregnanolone concentrations and tic frequency

2 years

Treatment Details

Interventions

• Neuroactive Steroids
• Tic suppression task

Trial Overview 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.

Participant Groups

Group I: Tic suppression Experimental Treatment 1 Intervention

Children with tics will undergo a tic suppression experimental paradigm.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

References

1. England pubmed.ncbi.nlm.nih.gov

An international perspective on Tourette syndrome: selected findings from 3,500 individuals in 22 countries. [2022]

2. England pubmed.ncbi.nlm.nih.gov

An experimental evaluation of tic suppression and the tic rebound effect. [2005]

3. England pubmed.ncbi.nlm.nih.gov

Prefrontal allopregnanolone mediates the adverse effects of acute stress in a mouse model of tic pathophysiology. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Isoallopregnanolone reduces tic-like behaviours in the D1CT-7 mouse model of Tourette syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Controlled stimulant treatment of ADHD and comorbid Tourette's syndrome: effects of stimulant and dose. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Allopregnanolone mediates the exacerbation of Tourette-like responses by acute stress in mouse models. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Steroid hormones and CNS sexual dimorphisms modulate symptom expression in Tourette's syndrome. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Tic reduction with pergolide in a randomized controlled trial in children. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The impact of a stress induction task on tic frequencies in youth with Tourette Syndrome. [2011]