Skip to main content
OpenTrials
Completed

NCT Number: NCT01883960

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change from baseline of Quality of life in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Measures for healthy adults and stroke patients are World Health Organization Quality of Life (WHOQOL-Taiwan). In addition to the above measures for healthy adults, measures for stroke patients also includeStroke Impact Scale (SIS), etc.

    Measures for QOL healthy children and CP are SF-36. In addition, measures for CP also include the Cerebral Palsy Quality of Life for Children (CP-QOL), etc.

  2. Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Healthy adults and stroke patients: Mini Mental Statement Examination (MMSE), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), Box-Block Test (BBT), Nine-Hole Peg test, Time up and go, Berg Balance Scale (BBS), Functional Independence Measure (FIM), Frequency Activity Index (FAI), etc.

  3. Change from baseline of movement and participation for stroke patients in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Measures for stroke patients also include Fugl-Meyer Assessment (FMA), Stroke Impact Scale (SIS), etc.

  4. Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Healthy children and CP: Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2), WMFT, BBT, Time up and go, Berg Balance Scale (BBS), Functional Independence Measure for Children (WeeFIM), Children Assessment of Participation and Enjoyment (CAPE), and School Function Assessment (SFA).

  5. Change from baseline of movement and participation for CP in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Measures for CP also include Gross motor function measure (GMFM), Quality of upper extremity test (QUEST), Pediatric Motor Activity Log (PMAL), Caregiver Functional Use Survey (CFUS), etc.

  6. Change from baseline of kinematic analysis in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    Kinematic analysis for upper limb and gait analysis

  7. Change from baseline of severity for stroke patients in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    stroke patients: Brunnstrom's stage, Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), strength and endurance, NIH Stroke Scale (NIHSS), etc

  8. Change from baseline of severity for CP patients in 6 months and 12 months

    Time frame: baseline, 6 months, 12 months

    CP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2013
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.