Accelerated Diffusion MRI for Diagnosis of Hungtington Disease

NCT01884181 | Completed DMC

• 1 other identifier: 102-1056B
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of the project are

1. 1.Diffusion MRI using compressed sensing could have reduced motion sensitivity and improved susceptibility related artifact because of accelerated acquisition.
2. 2.The macromolecule deposition in the brain of patients with Huntington Disease (HD) can lead to changes detectible by diffusion MRI.

Conditions

Huntington Disease

Keywords

Huntington Disease, diffusion MRI, diagnosis, fast imaging

Outcome Measures

Primary Outcomes (1)

• 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

  the 30th month

Secondary Outcomes (1)

• Diagnosis Huntington Disease

  end of the fourth year

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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:

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Wang . Jiun-Jie: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

ChangGung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Huntington Disease; Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiun-Jie Wang, PhD

  ChangGung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 21, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

TW (1)