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A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629655
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : June 5, 2009
Sponsor:
Collaborators:
Ministry of Finance, China
Capital Medical University
Information provided by:
China Rehabilitation Research Center

Tracking Information
First Submitted Date February 27, 2008
First Posted Date March 6, 2008
Last Update Posted Date June 5, 2009
Study Start Date February 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2009)
fMRI [ Time Frame: one day ]
Original Primary Outcome Measures
 (submitted: March 5, 2008)
fMRI [ Time Frame: at once ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation
Official Title A Spinal fMRI Study of Resting-State, Motor Task and Acupoint Stimulation
Brief Summary The spinal cord is a very important part of the central nervous system. fMRI can be applied to observe functional status of the human spinal cord. Under different conditions, the investigators will see different types of fMRI signals within the spinal cord. In resting state, the investigators might see active/inactive signals, too.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population group 1: male residents of Beijing group 2: male stroke patients of Beijing Boai hospital
Condition Cerebral Infarction
Intervention Other: motor task, sensory stimulation

motor task: finger tapping, simple type and complex type

sensory stimulation: electric or tactile stimulation

Other Names:
  • group 1:healthy people
  • group 2:patients with cerebral infarction,chronic stage
Study Groups/Cohorts
  • 1
    healthy people, male
    Intervention: Other: motor task, sensory stimulation
  • 2
    male patients with cerebral infarction, chronic stage
    Intervention: Other: motor task, sensory stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 4, 2009)
22
Original Estimated Enrollment
 (submitted: March 5, 2008)
20
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria (for healthy people):

  • Chinese male residents
  • right handed
  • no history of psychological/psychotic problems
  • no history of important diseases

Exclusion Criteria (for healthy people):

  • with factors which make subjects unsuitable to receive MR examination
  • history of important diseases

Inclusion Criteria (for patients):

  • Chinese male patients with ischemic stroke (CT/MRI scan confirmed)
  • right handed
  • at least 1.5 months from onset of stroke
  • ability to follow complex commands

Exclusion Criteria (for patients):

  • hemodynamic instability
  • history of dementia
  • inability to give consent because of impaired cognition or receptive aphasia
  • diseases in spine/spinal cord
  • with factors which make subjects unsuitable to receive MR examination
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00629655
Other Study ID Numbers 2007CZ-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pengxu Wei, China Rehabilitation Research Center
Study Sponsor China Rehabilitation Research Center
Collaborators
  • Ministry of Finance, China
  • Capital Medical University
Investigators
Principal Investigator: Pengxu Wei, Master China Rehabilitation Research Center
PRS Account China Rehabilitation Research Center
Verification Date June 2009