Clinical trial NCT01883960: A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage
Official title: A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Stroke
Keywords: cerebral palsy
cerebral vascular accident
multi-modal brain techniques
MRI
motor control
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CP and CVA, and healthy children, and adults

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of fMRI analysis in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline of Quality of life in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of movement and participation for stroke patients in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of movement and participation for CP in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of kinematic analysis in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of severity for stroke patients in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of severity for CP patients in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
name: Chia-Ling Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: