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Clinical Trials/NCT01883960
NCT01883960
Completed
N/A

A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies

Chang Gung Memorial Hospital1 site in 1 country150 target enrollmentSeptember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Chang Gung Memorial Hospital
Enrollment
150
Locations
1
Primary Endpoint
Change from baseline of fMRI analysis in 6 months and 12 months
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) and stroke patients.

Detailed Description

Brain damage may lead to various motor deficits, which further influence the activities and participation. Cerebral palsy (CP) and cerebral vascular accident (CVA) are the common disorder for congenital and acquired brain damage, respectively. It would be ideal to characterize neural network in patients with brain damage that underlies their clinical behavior by identifying altered neural network associated with behavioral improvement. The investigators hypothesize that the level of motor control and impact of brain image will change with time in patients with brain damage. Under this hypothesis, the measures of motor control are correlated with neural changes reflected by imaged using structural MRI, resting state fcMRI, and active fMRI sequences. The aim of this study is to investigate the motor control and brain image in patients with brain damage evaluated by clinical measures and multimodel imaging studies such as structural MRI, resting state fcMRI, and active fMRI. The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in CP and stroke patients. This study will be executed in 3 years: 1st phase: to establish the multimodal brain images and motor control in healthy subjects; 2nd phase: to establish the brain images and motor control in patients with stroke.; and 3rd phase: to establish the brain images and motor control in patients with CP. Additionally, the association between brain images and clinical changes involving movement and participation will be analyzed. The investigators will identify the predictors influencing final outcome and analyze. The differences in structural image, functional connectivity and brain activation between patients with brain damage and healthy controls can potentially be a bio-marker for prognosis. The investigators believe the results of this study will allow clinicians to understand the brain mechanisms underling motor control and early predict the outcome for patients with brain damage.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • CP-patients with CP and aged 6-18 years
  • CVA-patients with stroke and aged 40-75 years

Exclusion Criteria

  • contraindication to MRI
  • history of psychiatric disease
  • received BTX-A injection or surgery in recent six months
  • severe psychological impairments, such as mental retardation, autism or severe communication problems
  • progressive disorders, such as neurodegenerative disease
  • active medical disease, such as infection

Outcomes

Primary Outcomes

Change from baseline of fMRI analysis in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

fcMRI at resting, active-task fMRI. DTI

Secondary Outcomes

  • Change from baseline of movement and participation for stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of kinematic analysis in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of severity for stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of severity for CP patients in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Quality of life in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of movement and participation for CP in 6 months and 12 months(baseline, 6 months, 12 months)

Study Sites (1)

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