The Pathophysiology of Tourette Syndrome: a Multimodal Study

Tourette Syndrome Clinical Trial

— PTS  

Official title:

fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02497807
• Other study ID #: SAHZJU_CCBD_TouretteS
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2014
• Last updated: April 26, 2016
• Start date: December 2013
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to characterize the functional and anatomical connectivity changes in Tourette syndrome and its relation with iron deficiency.

Description:

Tourette syndrome (TS) is a childhood-onset chronic neuropsychiatric disorder with an increasing prevalence (range 0.05-3%).The investigators previous study showed that lower serum ferritin and iron levels in children with Tourette syndrome than in healthy children. The exact mechanism explaining how iron deficiency contributes to the pathophysiology of TS is unclear.One question is whether or not peripheral iron deficiency in children with Tourette syndrome can inflence the brain extrapyramid structure and resting state brain function？Another question is how well peripheral iron indices correlate with central iron content？ The third question is for TS children with peripheral iron deficiency, oral iron supplement (5mg/Kg/d) at least 8 weeks, the peripheral iron indicies return to normal levels, how the brain iron contents and the relative structure and brain function change?, To test the above-metioned hypothesis, functional magnetic resonance imaging (fMRI) , diffusion tensor imaging (DTI) and susceptibility weighted imaging (SWI) are applied to investigate the volume change of extrapyramid structure such as caudate nucleus and putamen, resting-state brain function and brain iron content before and after oral iron supplementation in TS children with peripheral iron deficiency, TS children with peripheral normal iron levels and normal healthy controls. The investigators hope to confirm that iron deficiency may play a causal role in the dopamine metabolism and it helps to further explore the pathophysiology of Tourette syndrome and also would contribute to significant advance in the therapeutic option for TS children with peripheral iron deficiency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• 6-12 years old

• Characterized by vocal tic and muscle twitch

• No positive signs was found through neurological examination, no significant psychomotor retardation,

Exclusion Criteria:

• Hepatolenticular degeneration

• Rheumatic chorea

• Myoclonic epilepsy

• History of mental disease or brain trauma

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Locations

Country	Name	City	State
China	Second Affiliated Hospital,Zhejiang University,School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency	Amplitude of low frequency fluctuation of BOLD signal has proven to be a promising way to detect disease-related local brain activity.This study investigate ALFF in Tourette syndrome and provides insights into the pathological mechanism of Tourette syndrome	two years	Yes
Secondary	Brain iron levels in Tourette syndrome		two years	Yes