Tourette SyndromePTSNCT02497807
The Pathophysiology of Tourette Syndrome: a Multimodal Study
An observational study of Tourette Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Apr 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients were recruited from outpatients or inpatients with Tourette syndrome.
Who may be able to join
- 6-12 years old
- Characterized by vocal tic and muscle twitch
- No positive signs was found through neurological examination, no significant psychomotor retardation,
Who cannot join
- Hepatolenticular degeneration
- Rheumatic chorea
- Myoclonic epilepsy
- History of mental disease or brain trauma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital,Zhejiang University,School of Medicine
Hangzhou, Zhejiang, 310009
Jianhua Feng, Doctor, 13588172577, zeek2013@sina.com
Jianhua Feng, Doctor
About this study
Official title: fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome
The purpose of this study is to characterize the functional and anatomical connectivity changes in Tourette syndrome and its relation with iron deficiency.
Read the 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.
- Conditions
- Tourette Syndrome
- Keywords
- Tourette syndrome, Iron deficiency
- Medical subject headings
- Tourette Syndrome, Iron Deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Secondary outcomes (1)
Brain iron levels in Tourette syndrome
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startDec 2013
- Primary completionNov 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Hua Feng, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Jianhua Feng, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineJianhua Feng, Doctor, Principal investigator, Secon Affiliated Hospital,Zhejiang University,School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497807
- Sponsor's protocol ID
- SAHZJU_CCBD_TouretteS
- Acronym
- PTS
- Status last verified
- Apr 2016
- First submitted
- 13 May 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Study on Iron Deficiency in the Pathological Mechanism of Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02497807
- Acronym / sponsor ID
- PTS / SAHZJU_CCBD_TouretteS
- Conditions
- Tourette Syndrome
- Keywords
- Tourette syndrome, Iron deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients were recruited from outpatients or inpatients with Tourette syndrome.
Key inclusion criteria (3 listed)
- 6-12 years old
- Characterized by vocal tic and muscle twitch
- No positive signs was found through neurological examination, no significant psychomotor retardation,
Key exclusion criteria (4 listed)
- Hepatolenticular degeneration
- Rheumatic chorea
- Myoclonic epilepsy
- History of mental disease or brain trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency
Time frame: 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
1 secondary outcome
Brain iron levels in Tourette syndrome
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Second Affiliated Hospital,Zhejiang University,School of Medicine
Hangzhou, China
Jianhua Feng, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Jianhua Feng, Doctor principal investigator
Secon Affiliated Hospital,Zhejiang University,School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of low frequency fluctuation of BOLD signal in Tourette syndrome and its relation with iron deficiency (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.