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

November 30, 2010 updated by: National Taiwan University Hospital

PET in Evaluating Cerebral Glucose Metabolism and Functional Change for Patients With Spinal Cord Injury

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Taiwan
      • Taipei, Taiwan, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

right handed patients with spinal cord injury

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
normal control
spinal cord injury 1
spinal cord injury 2
spinal cord injury 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yen-Ho Wang, M.D, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200612018R
  • NSC 96-2314-B-002-085-MY3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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