NCT02497807

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

May 13, 2014

Last Update Submit

April 26, 2016

Conditions

Tourette Syndrome

Keywords

Tourette syndromeIron deficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Brain iron levels in Tourette syndrome

    two years

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients were recruited from outpatients or inpatients with Tourette syndrome.

You may qualify if:

  • years old
  • Characterized by vocal tic and muscle twitch
  • No positive signs was found through neurological examination, no significant psychomotor retardation,

You may not qualify if:

  • Hepatolenticular degeneration
  • Rheumatic chorea
  • Myoclonic epilepsy
  • History of mental disease or brain trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital,Zhejiang University,School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

no biospecimens are to be retained

MeSH Terms

Conditions

Tourette SyndromeIron Deficiencies

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jianhua Feng, Doctor

    Second affiliated hospital,zhejiang University,school of medicine,

    PRINCIPAL INVESTIGATOR

  • Jianhua Feng, Doctor

    Secon Affiliated Hospital,Zhejiang University,School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

May 13, 2014

First Posted

July 15, 2015

Study Start

December 1, 2013

Primary Completion

November 1, 2016

Study Completion

April 1, 2017

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

CN(1)