Cerebral InfarctionNCT00629655
A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation
An observational study of Cerebral Infarction, run by China Rehabilitation Research Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- motor task, sensory stimulation
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Feb 2008to Apr 2009
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: group 1: male residents of Beijing group 2: male stroke patients of Beijing Boai hospital
Who may be able to join
- Chinese male residents
- right handed
- no history of psychological/psychotic problems
- no history of important diseases
- 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
Who cannot join
- with factors which make subjects unsuitable to receive MR examination
- history of important diseases
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Spinal fMRI Study of Resting-State, Motor Task and Acupoint Stimulation
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.
- Conditions
- Cerebral Infarction
- Being tested
- motor task, sensory stimulation
- Keywords
- fMRI, spinal cord, human, health, cerebral infarction, healthy
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor task, sensory stimulationOther
Also called group 1:healthy people, group 2:patients with cerebral infarction,chronic stage
motor task: finger tapping, simple type and complex type
sensory stimulation: electric or tactile stimulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | healthy people, male Receives: Other: motor task, sensory stimulation | |
| 2 | male patients with cerebral infarction, chronic stage Receives: Other: motor task, sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Rehabilitation Research Center
- Sponsor type
- Other government
- Collaborators
- Ministry of Finance, China, Capital Medical University
- Investigators
- Pengxu Wei, Master, Principal investigator, China Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629655
- Sponsor's protocol ID
- 2007CZ-4
- Status last verified
- Jun 2009
- First submitted
- 27 Feb 2008
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Spinal fMRI Study of Resting-State, Motor Task and Acupoint Stimulation
- ClinicalTrials.gov ID
- NCT00629655
- Acronym / sponsor ID
- 2007CZ-4
- Conditions
- Cerebral Infarction
- Keywords
- fMRI, spinal cord, human, health, cerebral infarction, healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- China Rehabilitation Research CenterOther government
- Collaborators
- Ministry of Finance, China, Capital Medical University
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Mar 2008 (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 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: motor task, sensory stimulationhealthy people, male |
| 2 | – | Other: motor task, sensory stimulationmale patients with cerebral infarction, chronic stage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- group 1: male residents of Beijing group 2: male stroke patients of Beijing Boai hospital
Key inclusion criteria (8 listed)
- Chinese male residents
- right handed
- no history of psychological/psychotic problems
- no history of important diseases
- Chinese male patients with ischemic stroke (CT/MRI scan confirmed)
Key exclusion criteria (7 listed)
- with factors which make subjects unsuitable to receive MR examination
- history of important diseases
- hemodynamic instability
- history of dementia
- inability to give consent because of impaired cognition or receptive aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor task, sensory stimulationAlso: group 1:healthy people, group 2:patients with cerebral infarction,chronic stagemotor task: finger tapping, simple type and complex type sensory stimulation: electric or tactile stimulation | Other | 1, 2 |
Primary outcome
fMRI
Time frame: one day
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 5 Jun 2009.
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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.
Pengxu Wei, Master principal investigator
China Rehabilitation Research Center
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 Infarction, run by China Rehabilitation Research Center at 1 site in China.
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 8 inclusion and 7 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 5 Jun 2009. 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 China. 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?
fMRI (time frame: one day). 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 5 Jun 2009.