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

NCT01883960 | Completed DMC

• 2 other identifiers: 99-1732BCMRPG391671
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Stroke

Keywords

cerebral palsy; cerebral vascular accident; multi-modal brain techniques; MRI; motor control

Outcome Measures

Primary Outcomes (1)

• Change from baseline of fMRI analysis in 6 months and 12 months

  fcMRI at resting, active-task fMRI. DTI

  baseline, 6 months, 12 months

Secondary Outcomes (8)

• Change from baseline of Quality of life in 6 months and 12 months

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CP and CVA, and healthy children, and adults

You may qualify if:

• CP-patients with CP and aged 6-18 years
• CVA-patients with stroke and aged 40-75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy; Stroke

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chia-Ling Chen, PhD

  Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 21, 2013
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 11, 2015

Record last verified: 2011-06

Locations

TW (1)