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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883960
• Other study ID #: 99-1732B
• Secondary ID: CMRPG391671
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: February 10, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Stroke

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of fMRI analysis in 6 months and 12 months	fcMRI at resting, active-task fMRI. DTI	baseline, 6 months, 12 months	No
Secondary	Change from baseline of Quality of life in 6 months and 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.	baseline, 6 months, 12 months	No
Secondary	Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 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.	baseline, 6 months, 12 months	No
Secondary	Change from baseline of movement and participation for stroke patients in 6 months and 12 months	Measures for stroke patients also include Fugl-Meyer Assessment (FMA), Stroke Impact Scale (SIS), etc.	baseline, 6 months, 12 months	No
Secondary	Change from baseline of movement and participation for Healthy children and CP in 6 months and 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).	baseline, 6 months, 12 months	No
Secondary	Change from baseline of movement and participation for CP in 6 months and 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.	baseline, 6 months, 12 months	No
Secondary	Change from baseline of kinematic analysis in 6 months and 12 months	Kinematic analysis for upper limb and gait analysis	baseline, 6 months, 12 months	No
Secondary	Change from baseline of severity for stroke patients in 6 months and 12 months	stroke patients: Brunnstrom's stage, Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), strength and endurance, NIH Stroke Scale (NIHSS), etc	baseline, 6 months, 12 months	No
Secondary	Change from baseline of severity for CP patients in 6 months and 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	baseline, 6 months, 12 months	No