Cerebral PalsyNCT01883960
A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage
An observational study of Cerebral Palsy and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Stroke
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: CP and CVA, and healthy children, and adults
Who may be able to join
- CP-patients with CP and aged 6-18 years
- CVA-patients with stroke and aged 40-75 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies
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.
Read the 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.
- Conditions
- Cerebral Palsy, Stroke
- Keywords
- cerebral palsy, cerebral vascular accident, multi-modal brain techniques, MRI, motor control
- Medical subject headings
- Cerebral Palsy, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of fMRI analysis in 6 months and 12 months
fcMRI at resting, active-task fMRI. DTI
Measured: baseline, 6 months, 12 months
Secondary outcomes (8)
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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).
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
Change from baseline of kinematic analysis in 6 months and 12 months
Kinematic analysis for upper limb and gait analysis
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, PhD, Principal investigator, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883960
- Sponsor's protocol ID
- 99-1732B
- Other IDs
- CMRPG391671
- Status last verified
- Jun 2011
- First submitted
- 10 Jun 2013
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies
- ClinicalTrials.gov ID
- NCT01883960
- Acronym / sponsor ID
- 99-1732B
- Conditions
- Cerebral Palsy, Stroke
- Keywords
- cerebral palsy, cerebral vascular accident, multi-modal brain techniques, MRI, motor control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CP and CVA, and healthy children, and adults
Key inclusion criteria (2 listed)
- CP-patients with CP and aged 6-18 years
- CVA-patients with stroke and aged 40-75 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Change from baseline of Quality of life in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
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
Change from baseline of movement and participation for stroke patients in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
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
Change from baseline of movement and participation for CP in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of kinematic analysis in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of severity for stroke patients in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of severity for CP patients in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, PhD principal investigator
Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of fMRI analysis in 6 months and 12 months (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.