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Trial record 2 of 13 for:    tourette's fMRI

The Pathophysiology of Tourette Syndrome: a Multimodal Study (PTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor:
Information provided by (Responsible Party):
Jian Hua Feng, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT02497807
First received: May 13, 2014
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to characterize the functional and anatomical connectivity changes in Tourette syndrome and its relation with iron deficiency.

Condition
Tourette Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:

Primary Outcome Measures:
  • Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    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:
  • Brain iron levels in Tourette syndrome [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained
no biospecimens are to be retained

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients were recruited from outpatients or inpatients with Tourette syndrome.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02497807

Locations
China, Zhejiang
Second Affiliated Hospital,Zhejiang University,School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Jianhua Feng, Doctor    13588172577    zeek2013@sina.com   
Principal Investigator: Jianhua Feng, Doctor         
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
  More Information

Responsible Party: Jian Hua Feng, professor of medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT02497807     History of Changes
Other Study ID Numbers: SAHZJU_CCBD_TouretteS 
Study First Received: May 13, 2014
Last Updated: April 26, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Tourette syndrome
Iron deficiency

Additional relevant MeSH terms:
Tourette Syndrome
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016