NCT04472325

Brief Summary

The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Therefore, we propose that the whole brain parcellation of diffusion MRI can be used to improve the diagnosis and prediction of clinical outcomes in Parkinson's Disease.

  1. 1.A regression model between clinical severity and two-year clinical outcomes and diffusion properties from multiple parcellated regions will be developed.
  2. 2.Blind validation will be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

June 14, 2020

Last Update Submit

August 5, 2021

Conditions

Parkinson Disease

Keywords

Magnetic Resonance ImagingNeurodegeneration diseaseCognitive impairmentDiagnosisPrognosis

Outcome Measures

Primary Outcomes (1)

  • An objective image-based evidence for the diagnosis, differential diagnosis and prognosis of Parkinson's Disease

    The following will be measured for the diagnostic performance of diffusion MRI: 1. Regression between cognitive performance and baseline diffusion MRI using Pearson correlation 2. Leave one out cross validation

    end of the third year

Secondary Outcomes (5)

  • prognosis

    end of the third year

  • prognosis

    end of the third year

  • differential diagnosis

    end of the second year

  • Imaging

    end of the third year

  • Imaging

    end of the third year

Study Arms (3)

Atypical Parkinson's Disease patients

This group consists of patients includes 35 patients with Progressive Supranuclear Paralysis (PSP), 35 patients with Multiple System Atrophy (MSA), and 35 patients with Cortico-Basal Degeneration (CBD).

Idiopathic Parkinson's Disease patients

This group consists of patients starting from 2012 to 2013 and includes 87 patients with typical Parkinson's Disease (PD)

Healthy volunteers

The 96 healthy volunteers should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. MMSE score greater than or equal to 26 4. Able to understand study requirements and give informed consent

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. Able to understand study requirements and give informed consent 4. Agree to return for follow-up checks 5. Able to suspend intake of medication for at least 12 hours

You may not qualify if:

  • Cardiac pacemaker or defibrillator implantation Intracranial metal device implantation
  • Other major systemic diseases, such as renal failure, heart failure, stroke, AMI/unstable angina, poorly controlled diabetes mellitus, poorly controlled hypertension
  • Alcohol or drug abuse
  • Moderate to severe dementia
  • Severe movement disorders
  • History of intracranial surgery including thalamotomy, pallidotomy, and/or deep brain stimulation
  • Major physical or neuropsychiatric disorders
  • Structural abnormalities that may cause dementia, such as cortical infarction, tumour, or subdural hematoma
  • Besides medication for Parkinson's Disease, taking other medication with substances that can pass through the blood-brain barrier
  • Besides medication for Parkinson's Disease, taking other medication for more than 10 years
  • Treatments or concurrent illnesses other than Alzheimer's Disease that could interfere with cognitive function
  • Meet the criteria for dementia (DSM-IV)
  • Head trauma with loss of consciousness greater than 10 minutes
  • Severe loss of sensation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangGung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionDisease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

June 14, 2020

First Posted

July 15, 2020

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

July 31, 2020

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

TW(1)