Exploring the Role of Neuroactive Steroids in Tourette Syndrome
ConditionTourette Syndrome in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity of Utah
About this trial
Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. The studies proposed in this application will explore the endocrine mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. In particular, our exploratory studies will characterize the steroid profile in TS-affected boys and girls to identify novel potential biomarkers and therapeutic targets for this disorder.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnostic criteria of TS for cases (and lack of any tic disorders for controls)
Age between 8 and 12 years old (this age range is to ensure that TS participants can perform the tic suppression task)
confirmation of sexual development by parent and/or self-reported Tanner stage of pubic hair development.
Disqualifiers
major psychiatric disorders such as a psychotic disorder, autism spectrum disorder, conduct disorder, and substance use disorder;
other neurological disorders;
clinically significant endocrinological disorders;
use of therapies that can modify hormonal profile;
Trial design
Design model
Single group
Treatments tested in this trial
Tic suppression task
BehavioralTic Suppression Task (TST, administered to Tourette syndrome participants only): At the beginning of the task, the child participant will be seated alone in front of a computer monitor with a countdown timer visible on the screen. For the first 10 minutes (baseline condition) they will be asked to tic freely and not to try to suppress their tics. For the second 10 minutes children will be asked to suppress their tics and will receive points for successful suppression. Participants will then be asked to sit alone in the room and tic freely for an additional 10-minutes.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Tic suppressionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Salivary allopregnanolone concentrations
Change of concentrations of salivary allopregnanolone, as measured by chromatography/ mass spectrometry. All concentrations will be expressed in pg/ml.
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Tic frequency
Direct observation
Time frame
Through study completion, an average of 2 yearsOther outcomes
1
Measurement of salivary concentrations of other neuroactive steroids
Changes in concentrations of pregnenolone, 17-hydroxypregnenolone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, androstenediol, progesterone, androstenedione, testosterone, dihydroprogesterone, dihydrotestosterone, isoallopregnanolone, pregnanolone, epipregnanolone, 3-alpha androstanediol, androsterone, epiandrosterone, etiocholanolone, and cortisol as measured by chromatography/ mass spectrometry. All concentrations will be expressed in pg/ml.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
University of Miami
Collaborator
Albert Einstein College of Medicine
Collaborator
Source ClinicalTrials.gov