- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05281445
Exploring the Role of Neuroactive Steroids in Tourette Syndrome (NS in TS)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. Available treatment strategies remain unsatisfactory, due to limited knowledge of the biological foundations of this disorder. The studies proposed in this application will explore the mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. Studies from the investigators suggest that these features of TS are contributed by neuroactive steroids, a family of mediators implicated in sex and stress regulation.
The typical age of onset of TS is 6-7 years, coinciding with adrenarche, a phase of adrenal maturation characterized by an upsurge in adrenal neuroactive steroids, such as dehydroepiandrosterone (DHEA) and its sulfate (DHEAS). In preliminary studies, the investigators found that DHEA exacerbated tic-like responses in animal models of TS. Interestingly, the dose of DHEA needed to elicit TS-like responses in females is higher than those needed in males, possibly pointing to a mechanism of sex differences in TS.
Stress reduces the ability of TS patients to suppress tics, but the underlying mechanisms remain unknown. Studies in animal models indicate that this process may be due to the elevation of the neuroactive steroid allopregnanolone (AP) in the prefrontal cortex. By inhibiting the ability of the prefrontal cortex to suppress tics, AP promotes tic execution. In a pilot study, the investigators found that tic suppression, a well-known stressful task in TS patients, increases AP salivary levels. Furthermore, in another proof-of-concept study, the investigators found that inhibiting AP synthesis led to a reduction in tic severity and facilitated voluntary control of tics in stressful situations.
These findings lead to the hypothesis that TS patients exhibit alterations of the composition of their neuroactive steroid profiles, including: 1) an increase in baseline DHEA(S) levels in male TS patients, in correlation with life-time severity; and 2) an exaggerated elevation in AP in response to acute stress.
The two Aims of this proposal will test this hypothesis by: 1) comparing the baseline urinary steroidomic profile of TS-affected boys and girls with non-affected sex- and age-matched controls; and 2) charting the dynamic alterations in steroidomic salivary profiles in response to tic suppression. These studies will advance understanding of the endocrine mechanisms in TS and lead to the identification of potential biomarkers for the severity of tics and comorbid symptoms. In the long run, the results of these studies may open the way for the development of new therapies for TS that may reduce tic severity and increase patients' responsiveness to behavioral interventions.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Marco Bortolato, MD PhD
- Numero di telefono: 8015873352
- Email: marco.bortolato@utah.edu
Backup dei contatti dello studio
- Nome: Michael Himle, PhD
- Numero di telefono: 8015817529
- Email: michael.himle@utah.edu
Luoghi di studio
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84112
- University of Utah
-
Contatto:
- Michael Himle, PhD
- Numero di telefono: 801-581-7529
- Email: michael.himle@utah.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- pharmacotherapies that may change stress sensitivity, such as antidepressants and anxiolytics.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Tic suppression
Children with tics will undergo a tic suppression experimental paradigm.
|
Tic 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Salivary allopregnanolone concentrations
Lasso di tempo: Through study completion, an average of 2 years
|
Change of concentrations of salivary allopregnanolone, as measured by chromatography/ mass spectrometry.
All concentrations will be expressed in pg/ml.
|
Through study completion, an average of 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tic frequency
Lasso di tempo: Through study completion, an average of 2 years
|
Direct observation
|
Through study completion, an average of 2 years
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Measurement of salivary concentrations of other neuroactive steroids
Lasso di tempo: Through study completion, an average of 2 years
|
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.
|
Through study completion, an average of 2 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marco Bortolato, MD PhD, University of Utah
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Processi patologici
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Patologia
- Malattie genetiche, congenite
- Malattie dei gangli basali
- Disturbi del movimento
- Malattie Neurodegenerative
- Malattie Eredodegenerative, Sistema Nervoso
- Disturbi del neurosviluppo
- Disturbi da tic
- Sindrome
- Sindrome di Tourette
Altri numeri di identificazione dello studio
- 00150143
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .