A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage

NCT ID: NCT01883960

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy adults

Inclusion criteria for healthy adults were as follows: 40-70 y/o; good cognition and cooperation; and healthy adults.

No interventions assigned to this group

stroke subjects

Inclusion criteria for subjects with brain damage by stroke were as follows: a diagnosis of first-time-onset stroke and aged 40-70 years old.

No interventions assigned to this group

CP subjects

Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 16-18 years old.

No interventions assigned to this group

healthy children

Inclusion criteria for healthy children were as follows: ages of 6-18 y/o ; good cognition and cooperation; and healthy children.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. CP-patients with CP and aged 6-18 years
2. CVA-patients with stroke and aged 40-75 years

Exclusion Criteria

1. contraindication to MRI
2. history of psychiatric disease
3. received BTX-A injection or surgery in recent six months
4. severe psychological impairments, such as mental retardation, autism or severe communication problems
5. progressive disorders, such as neurodegenerative disease
6. active medical disease, such as infection
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMRPG391671

Identifier Type: OTHER

Identifier Source: secondary_id

99-1732B

Identifier Type: -

Identifier Source: org_study_id

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