Positron Emission Tomography (PET) in Evaluating Cerebral Glucose Metabolism and Functional Change for Patients With Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00929422
First received: June 26, 2009
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

Background: Spinal cord injury (SCI) results in dysfunction of motor and sensory system and the hormonal secretion. Not only the change of peripheral hormonal organs, the central neurotransmitters were also affected. We consider there are some changes in cerebral physiology, anatomy or function after SCI.

Objective: Use PET imaging to investigate the brain functional difference among the SCI and control group.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: PET in Evaluating Cerebral Glucose Metabolism and Functional Change for Patients With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 160
Study Start Date: August 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
spinal cord injury 1
spinal cord injury 2
spinal cord injury 3
normal control

Detailed Description:

Spinal cord injury (SCI) results in dysfunction of motor and sensory system and the hormonal secretion. Not only the change of peripheral hormonal organs, the central neurotransmitters were also affected. We consider there are some changes in cerebral physiology, anatomy or function after SCI. Transcranial magnetic stimulation, magnetic coil or EEG were used to study the phenomenon of cortical reorganization in post-injury of spinal cord. Now functional imaging render the researcher easier to understand adaptive changes of cerebral cortex in patients with SCI. Due to the development of positron emission tomography (PET) and adequate supply of 18-F-deoxyglucose (FDG), the cerebral glucose metabolism and blood flow were approached in easier way. PET was used in patients with cervical compressive myelopathy to evaluate the glucose metabolic rate. Standardized uptake value of FDG and its association with neurological status of pre- and post-operation had been studied. PET was also used to assess the effect of a transverse cord lesion on cerebral energy metabolism in view of sensorimotor reorganization. In addition to FDG, 15O-H2O was applied to evaluate the activation adaptation of post-SCI cerebrum. 13N-NH3 was also used to study the cerebral blood flow by its concentration in brain tissue. Recently the alteration of regional cerebral blood flow was visualized by brain SPECT. We want to know the impact of spinal lesion and function impairment on brain activation in patients with SCI. 6-[18F]fluorodopa (18F-FDOPA) is indicator of brain presynaptic dopaminergic function, which can be used to evaluate the changes of brain dopamine. WE will use 18F-FDOPA-PET to investigate its difference among the SCI and control group.

In our three-year study, 40 men with SCI will be recruited each year, 40 age-matched men as control. In the first year study, FDG-PET will be used to assess the cerebral metabolism, then the glucose metabolic rate of cerebrum and spinal cord will be analyzed. The mechanism of cerebral adaptation after SCI may be clarified. 13N-NH3 will be used in the second year to evaluate the cerebral blood flow in the period of attempted and true action, then their difference will be analyzed by statistical parametric mapping. The picture of activated brain area will be compared between study and control group to investigate the reorganization of cerebral cortex after SCI. In the third year, we will use 18F-FDOPA to evaluate the brain presynaptic dopaminergic function among SCI and control group. Thus, we will delineate the effect of SCI on cerebral function by PET.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

right handed patients with spinal cord injury

Criteria

Inclusion Criteria:

  1. age above 18 years old
  2. spinal cord injury for over 1 year

Exclusion Criteria:

  1. epilepsy
  2. psychiatric disorder
  3. history of central neurologic system infection
  4. Parkinson's disease
  5. Alcoholic disease
  6. vitamine deficiency
  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: NCT00929422

Contacts
Contact: Yen-Ho Wang, MD 886-2-23123456 ext 67293 lukewang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, Taiwan, 100
Contact: Yen-Ho Wang, MD    886-2-23123456 ext 67293    lukewang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yen-Ho Wang, M.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Wang YH, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00929422     History of Changes
Other Study ID Numbers: 200612018R, NSC 96-2314-B-002-085-MY3
Study First Received: June 26, 2009
Last Updated: November 30, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
spinal cord injury
PET
cerebral function
cortical reorganization

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 02, 2014