PTS: The Pathophysiology of Tourette Syndrome: a Multimodal Study

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02497807
Collaborator
(none)
40
1
40
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome
    Study Start Date :
    Dec 1, 2013
    Anticipated Primary Completion Date :
    Nov 1, 2016
    Anticipated Study Completion Date :
    Apr 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency [two years]

      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

    Secondary Outcome Measures

    1. Brain iron levels in Tourette syndrome [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital,Zhejiang University,School of Medicine Hangzhou Zhejiang China 310009

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    • Principal Investigator: Jianhua Feng, Doctor, Second affiliated hospital,zhejiang University,school of medicine,
    • Principal Investigator: Jianhua Feng, Doctor, Secon Affiliated Hospital,Zhejiang University,School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian Hua Feng, professor of medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT02497807
    Other Study ID Numbers:
    • SAHZJU_CCBD_TouretteS
    First Posted:
    Jul 15, 2015
    Last Update Posted:
    Apr 27, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Jian Hua Feng, professor of medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2016