An observational study in Huntington Disease, sponsored by Wang . Jiun-Jie. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Wang . Jiun-Jie · Observational
The hypotheses of the project are
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.
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.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's enrollment of 80 is below the median of 90 across 78 observational studies indexed under Huntington Disease.
Browse Huntington Disease studies →Wang . Jiun-Jie is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Huntington Disease
Healthy Controls:
Exclusion Criteria:
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.
Established diagnosis by a neurological examination and genetic assessment of CAG expansion in the Htt gene.
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.
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
Time frame: the 30th month
Diagnosis Huntington Disease
Procedure: 1. Diffusion MRI will be acquired from patients with HD 2. Diagnostic performance will be analyzed when compared to the healthy control in Validation II in a case control study. 3. The correlation with disease severity and the image finding will be examined. Approach 1. 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.
Time frame: end of the fourth year
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Wang . Jiun-Jie