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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Stroke
Cerebral Palsy

Study type

Observational

Funder types

Other

Identifiers

NCT01883960
99-1732B
CMRPG391671 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

6 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

150 participants in 4 patient groups

healthy adults
Description:
Inclusion criteria for healthy adults were as follows: 40-70 y/o; good cognition and cooperation; and healthy adults.
stroke subjects
Description:
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.
CP subjects
Description:
Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 16-18 years old.
healthy children
Description:
Inclusion criteria for healthy children were as follows: ages of 6-18 y/o ; good cognition and cooperation; and healthy children.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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