Clinical trial NCT02497807: The Pathophysiology of Tourette Syndrome: a Multimodal Study
Official title: fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tourette Syndrome
Keywords: Tourette syndrome
Iron deficiency
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were recruited from outpatients or inpatients with Tourette syndrome.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency
timeFrame: two years
Secondary outcomes:
measure: Brain iron levels in Tourette syndrome
timeFrame: two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital,Zhejiang University,School of Medicine
state: Zhejiang
Study officials:
affiliation: Second affiliated hospital,zhejiang University,school of medicine,
name: Jianhua Feng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Secon Affiliated Hospital,Zhejiang University,School of Medicine
name: Jianhua Feng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: