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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01883960
First received: June 10, 2013
Last updated: June 19, 2013
Last verified: June 2011
  Purpose

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.


Condition
Cerebral Palsy
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Change from baseline of fMRI analysis in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    fcMRI at resting, active-task fMRI. DTI


Secondary Outcome Measures:
  • Change from baseline of Quality of life in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change from baseline of movement and participation for stroke patients in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Measures for stroke patients also include Fugl-Meyer Assessment (FMA), Stroke Impact Scale (SIS), etc.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change from baseline of movement and participation for CP in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline of kinematic analysis in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Kinematic analysis for upper limb and gait analysis

  • Change from baseline of severity for stroke patients in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    stroke patients: Brunnstrom's stage, Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), strength and endurance, NIH Stroke Scale (NIHSS), etc

  • Change from baseline of severity for CP patients in 6 months and 12 months [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    CP patients: Gross Motor Functional Classification System (GMFCS), Manual Ability Classification System (MACS), Modified Ashworth Scale (MAS), strength and endurance, selective control, etc


Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy adults
Inclusion criteria for healthy adults were as follows: 40-70 y/o; good cognition and cooperation; and healthy adults.
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.
CP subjects
Inclusion criteria for subjects with brain damage by CP were as follows: a diagnosis of CP and aged 16-18 years old.
healthy children
Inclusion criteria for healthy children were as follows: ages of 6-18 y/o ; good cognition and cooperation; and healthy children.

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

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

CP and CVA, and healthy children, and adults

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883960

Contacts
Contact: Chia-Ling Chen +886-3-3281200 ext 8147 clingchen@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, PHD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chia-Ling Chen, PhD Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01883960     History of Changes
Other Study ID Numbers: 99-1732B, CMRPG391671
Study First Received: June 10, 2013
Last Updated: June 19, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
cerebral palsy
cerebral vascular accident
multi-modal brain techniques
MRI
motor control

Additional relevant MeSH terms:
Cerebral Palsy
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014