StrokeNCT01239602
The Variation of Movement Related Cortical Potential, Cortico-cortical Inhibition, and Motor Evoked Potential in Intracerebral Implantation of Antologous Peripheral Blood Stem Cells(CD34)in Old Ischemic Stroke
An observational study of Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. We recruit these patients who received stem cell therapy and completed the study. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Oct 2010
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 36 patients suffered from old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image [T2WI] of MRI) between 6 months and 5 years of onset who had initial scores on the National Institute of Health stroke scale (NIHSS) of between 9 and 20.
Who may be able to join
- 1.old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image [T2WI] of MRI) 2.between 6 months and 5 years of onset 3.National Institute of Health stroke scale (NIHSS) of between 9 and 20.
Who cannot join
- 1.Seizure history 2. Pacemaker insertion
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taiwan, 404
Jui-cheng Chen, M.D., 886422052121 ext. 5039
About this study
Stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. We recruit these patients who received stem cell therapy and completed the study. We adopted movement-related cortical potential,and cortico-cortical inhibition to assess the stroke patients with or without stem cell therapy. Further analyzing the correlation of the motor related cortical potential and cortico-cortical inhibition among them. We wanted to find out if there are changes in cortical excitability in subjects with chronic stroke after stem cell therapy.
- Conditions
- Stroke
- Keywords
- changes in cortical excitability in subjects with chronic stroke after stem cell therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Not described | |
| with Stem cell therapy plus G-CSF | Not described | |
| G-CSF along | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239602
- Sponsor's protocol ID
- DMR99-IRB-200
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Variation of Movement Related Cortical Potential, Cortico-cortical Inhibition, and Motor Evoked Potential in Intracerebral Implantation of Antologous Peripheral Blood Stem Cells(CD34)in Old Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01239602
- Acronym / sponsor ID
- DMR99-IRB-200
- Conditions
- Stroke
- Keywords
- changes in cortical excitability in subjects with chronic stroke after stem cell therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 11 Nov 2010 (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.
Stem cell theray in old stroke patients is a study to treat stroke patients approved before in our hospital. We recruit these patients who received stem cell therapy and completed the study. We adopted movement-related cortical potential,and cortico-cortical inhibition to assess the stroke patients with or without stem cell therapy. Further analyzing the correlation of the motor related cortical potential and cortico-cortical inhibition among them. We wanted to find out if there are changes in cortical excitability in subjects with chronic stroke after stem cell therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | – |
| with Stem cell therapy plus G-CSF | – | – |
| G-CSF along | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 36 patients suffered from old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image [T2WI] of MRI) between 6 months and 5 years of onset who had initial scores on the National Institute of Health stroke scale (NIHSS) of between 9 and 20.
Key inclusion criteria (1 listed)
- 1.old cerebral infarction (middle cerebral artery territory as documented on the T2 weight image [T2WI] of MRI) 2.between 6 months and 5 years of onset 3.National Institute of Health stroke scale (NIHSS) of between 9 and 20.
Key exclusion criteria (1 listed)
- 1.Seizure history 2. Pacemaker insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
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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.
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 Stroke, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 11 Nov 2010.