Huntington DiseaseNCT01884181
Accelerated Diffusion MRI for Diagnosis of Hungtington Disease
An observational study of Huntington Disease, run by Wang . Jiun-Jie at 1 site in Taiwan.
Trial summary
The hypotheses of the project are 1. Diffusion MRI using compressed sensing could have reduced motion sensitivity and improved susceptibility related artifact because of accelerated acquisition. 2. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2017
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Healthy Controls: The healthy controls will be recruited from the local community, or the neurological clinic. The cognitive performance will be evaluated by Mini-Mental State Examination (MMSE). A complete physical and neurological examination will be performed. 2. Huntington Disease: Patients with Huntington Disease will be referred from the department of neurology in ChangGung Memorial Hospital, LinKou. Established diagnosis will be made by a neurological examination and genetic assessment of CAG expansion in the Htt gene. The severity and progression of the disease will be assessed by the Unified Huntington's Disease Rating Scale (UHDRS) (18). The cognitive performance will be evaluated by Mini-Mental State Examination (MMSE). The inclusion criteria are the following:
Who may be able to join
- Huntington Disease
- All participants should be aged between 20 and 70 year old.
- Established diagnosis by a neurological examination and genetic assessment of CAG expansion in the Htt gene.
- Able to understand and provide signed informed consent.
- Healthy Controls:
- Able to understand and provide signed informed consent
- age range and gender matched with Patients with HD
- without significant neuropsychiatric disorders
Who cannot join
- Human Subjects The participants will be divided into 2 groups: Huntington Disease Group and Healthy Control Group. All participants should be aged between 20 and 70 year old, right handed and gender balanced.
- Exclusion CriteriaThe following exclusion criteria apply to both groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Significant major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Pregnant or breast feeding women.
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- Severe dementia.
- Any documented abnormality of brain caused by etiologies other than HD by MRI and 18FDG PET studies, which might contribute to the cognitive function, such as hydrocephalus or encephalomalacia, will be excluded. Mild cortical atrophy will be allowed.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Significant physical disorder or neuropsychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerated Diffusion MRI as a Potential Image Based Biomarker for Hungtington Disease
The hypotheses of the project are
- Diffusion MRI using compressed sensing could have reduced motion sensitivity and improved susceptibility related artifact because of accelerated acquisition.
- The macromolecule deposition in the brain of patients with Huntington Disease (HD) can lead to changes detectible by diffusion MRI.
To validate the hypothesis that the new accelerated diffusion MRI technique could produce a new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index will be calculated using accelerated acquisition. The diagnostic performance will be evaluated for data reconstructed with and without acceleration. The correlation with the disease severity will be assessed.
Read the detailed description
Diffusion magnetic resonance imaging has emerged as a sensitive, noninvasive tool for assessing the abnormalities in the central nervous system. Applications have been reported in many neurological disorders. However, because of the motion-sensitizing diffusion gradient and the prolonged diffusion encoding time, clinical practice could be difficult especially in patients with motor disorders such as Huntington Disease. Currently there existed no useful biomarker which could reflect either the disease progression or severity of Huntington disease. There is a growing interest in imaging Huntington disease using diffusion magnetic resonance imaging because of its capability to depict the micro-environmental changes.
Unfortunately the excessive motor abnormality such as chorea yields the acquisition of diffusion magnetic resonance imaging unfeasible in a clinical setting. The diffusion MRI with compressed sensing demonstrated reduced motion sensitivity and improved susceptibility related artifact because of the accelerated acquisition. Because of the reduced acquisition time, diffusion MRI in patient with Huntington Disease would be possible. It is therefore expected that the macromolecule deposition in the brain of patients with HD can lead to detectible changes in diffusion properties. The accelerated diffusion MRI techniques will be used to acquire data from healthy volunteers and patients with Huntington disease. The aim of the study is to develop and optimize a novel accelerated diffusion Magnetic Resonance Imaging (MRI) technique using advanced compressed sensing techniques. The joint sparsity constraint algorithm will be implemented in an in-line reconstruction platform for the diffusion MRI processing.
The second aim is to test the efficiency of the new accelerated diffusion MRI technique from phantom and in healthy human. Finally to validate the hypothesis that the new accelerated diffusion MRI technique could produce a new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index will be calculated using accelerated acquisition. The diagnostic performance will be evaluated for data reconstructed with and without acceleration. The correlation with the disease severity will be assessed. A risk management report will be concluded at the end of project execution for registration in the department of health. The acceleration diffusion MRI could provide new insight to the etiology of the disease. The in-line image reconstruction platform could be used for pediatric or psychiatric patients who cannot hold still in the scanner for a prolonged period and in patients with movement disorders.
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease, diffusion MRI, diagnosis, fast imaging
- Medical subject headings
- Huntington Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Huntington Disease Group | Established diagnosis by a neurological examination and genetic assessment of CAG expansion in the Htt gene. | |
| Healthy Controls | 1. The healthy control subjects without a clinically significant neuropsychiatric disorders. 2. Able to understand and provide signed informed consent. 3. Age range and gender matched with Patients with Huntington Disease Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility study on healthy human.
Procedure:
Diffusion MRI will be acquired form healthy volunteers.
Approach:
Images will be acquired with and without compressed sensing DTI The reproducibility of compressed sensing diffusion MRI will be assessed in human
Measured: the 30th month
Secondary outcomes (1)
Diagnosis Huntington Disease
Procedure:
- Diffusion MRI will be acquired from patients with HD
- Diagnostic performance will be analyzed when compared to the healthy control in Validation II in a case control study.
- The correlation with disease severity and the image finding will be examined. Approach
- ROI selected from basal ganglia 2. The receiver operative characteristic analysis will be performed and the area under curve will be determined. 3. The disease severity will be assessed by Unified Huntington Disease Scale. The correlation will be assessed by Spearmann's Ranked correlation.
Measured: end of the fourth year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang . Jiun-Jie
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor-investigator, Wang . Jiun-Jie, Chang Gung Memorial Hospital
- Investigators
- Jiun-Jie Wang, PhD, Principal investigator, ChangGung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884181
- Sponsor's protocol ID
- 102-1056B
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Diffusion MRI as a Potential Image Based Biomarker for Hungtington Disease
- ClinicalTrials.gov ID
- NCT01884181
- Acronym / sponsor ID
- 102-1056B
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease, diffusion MRI, diagnosis, fast imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wang . Jiun-JieUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Jun 2013 (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 hypotheses of the project are
- Diffusion MRI using compressed sensing could have reduced motion sensitivity and improved susceptibility related artifact because of accelerated acquisition.
- The macromolecule deposition in the brain of patients with Huntington Disease (HD) can lead to changes detectible by diffusion MRI.
To validate the hypothesis that the new accelerated diffusion MRI technique could produce a new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index will be calculated using accelerated acquisition. The diagnostic performance will be evaluated for data reconstructed with and without acceleration. The correlation with the disease severity will be assessed.
Detailed description
Diffusion magnetic resonance imaging has emerged as a sensitive, noninvasive tool for assessing the abnormalities in the central nervous system. Applications have been reported in many neurological disorders. However, because of the motion-sensitizing diffusion gradient and the prolonged diffusion encoding time, clinical practice could be difficult especially in patients with motor disorders such as Huntington Disease. Currently there existed no useful biomarker which could reflect either the disease progression or severity of Huntington disease. There is a growing interest in imaging Huntington disease using diffusion magnetic resonance imaging because of its capability to depict the micro-environmental changes.
Unfortunately the excessive motor abnormality such as chorea yields the acquisition of diffusion magnetic resonance imaging unfeasible in a clinical setting. The diffusion MRI with compressed sensing demonstrated reduced motion sensitivity and improved susceptibility related artifact because of the accelerated acquisition. Because of the reduced acquisition time, diffusion MRI in patient with Huntington Disease would be possible. It is therefore expected that the macromolecule deposition in the brain of patients with HD can lead to detectible changes in diffusion properties. The accelerated diffusion MRI techniques will be used to acquire data from healthy volunteers and patients with Huntington disease. The aim of the study is to develop and optimize a novel accelerated diffusion Magnetic Resonance Imaging (MRI) technique using advanced compressed sensing techniques. The joint sparsity constraint algorithm will be implemented in an in-line reconstruction platform for the diffusion MRI processing.
The second aim is to test the efficiency of the new accelerated diffusion MRI technique from phantom and in healthy human. Finally to validate the hypothesis that the new accelerated diffusion MRI technique could produce a new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index will be calculated using accelerated acquisition. The diagnostic performance will be evaluated for data reconstructed with and without acceleration. The correlation with the disease severity will be assessed. A risk management report will be concluded at the end of project execution for registration in the department of health. The acceleration diffusion MRI could provide new insight to the etiology of the disease. The in-line image reconstruction platform could be used for pediatric or psychiatric patients who cannot hold still in the scanner for a prolonged period and in patients with movement disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huntington Disease Group | – | –Established diagnosis by a neurological examination and genetic assessment of CAG expansion in the Htt gene. |
| Healthy Controls | – | –1. The healthy control subjects without a clinically significant neuropsychiatric disorders. 2. Able to understand and provide signed informed consent. 3. Age range and gender matched with Patients with Huntington Disease Group. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Healthy Controls: The healthy controls will be recruited from the local community, or the neurological clinic. The cognitive performance will be evaluated by Mini-Mental State Examination (MMSE). A complete physical and neurological examination will be performed. 2. Huntington Disease: Patients with Huntington Disease will be referred from the department of neurology in ChangGung Memorial Hospital, LinKou. Established diagnosis will be made by a neurological examination and genetic assessment of CAG expansion in the Htt gene. The severity and progression of the disease will be assessed by the Unified Huntington's Disease Rating Scale (UHDRS) (18). The cognitive performance will be evaluated by Mini-Mental State Examination (MMSE). The inclusion criteria are the following:
Key inclusion criteria (8 listed)
- Huntington Disease
- Healthy Controls:
Key exclusion criteria (10 listed)
- Human Subjects The participants will be divided into 2 groups: Huntington Disease Group and Healthy Control Group. All participants should be aged between 20 and 70 year old, right handed and gender balanced.
- Exclusion CriteriaThe following exclusion criteria apply to both groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Significant major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
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
Feasibility study on healthy human.
Time frame: the 30th month
Procedure: Diffusion MRI will be acquired form healthy volunteers. Approach: Images will be acquired with and without compressed sensing DTI The reproducibility of compressed sensing diffusion MRI will be assessed in human
1 secondary outcome
Diagnosis Huntington Disease
Time frame: end of the fourth year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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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.
Jiun-Jie Wang, PhD principal investigator
ChangGung University
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 Huntington Disease, run by Wang . Jiun-Jie at 1 site in Taiwan.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility study on healthy human. (time frame: the 30th month). 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 18 Jul 2018.