Ischemic StrokeACFINCT01862172
Focal Cortical Atrophy After Myocardial Internal Capsule
A study testing Additional MRI in people with Ischemic Stroke, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule. The patient is compared to himself between day zero to ten and three months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Additional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2014
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 18 to 90 years old.
- Subcortical stroke
- Achievement of the internal capsule, according to MRI
- Ability to perform MRI within 10 days after the onset of symptoms
- NIHSS over or equal 2 and < 20
- Rankin Score over or equal 1 and ≤ 5
- Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign
- Affiliation to a social security scheme
Who cannot join
- Pregnant or nursing women
- Other cerebral lesion, concomitant or preexisting
- Concomitant disease causing unfavorable prognosis within 3 months after inclusion
- pre-existing psychiatric illness
- Alcoholism or other chronic intoxication
- Cortical localization of the infarction
Show all 11Show fewer
- Patient in a coma, who cannot be examined and evaluated
- Patient intubated, ventilated, sedated
- Cerebral hemorrhage, intra-parenchymal and / or subarachnoid
- Persons protected by law (guardianship, curators and judicial protection)
- Contraindications to magnetic resonance examination: pacemaker, metal implants, neurostimulators, Clips neurosurgical wire sutures, staples, metal heart valves, ventricular bypass valve, metal workers, foreign eye, shrapnel, bullet , cochlear implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.
The patient is compared to himself between day zero to ten and three months.
Read more
The study hypotheses are:
- A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
- This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
- This atrophy is correlated with disability at three months, assessed by Rankin score.
Read the detailed description
Twenty-two patients with ischemic stroke, subcortical, involving the internal capsule, will be included.
Each patient will be compared to himself, on day zero to ten and three months.
An MRI will be performed between day zero and ten, then three months of infarction sequences with traditional threeD enabling acquisition and tractography and The measurement of cortical thickness is in mm The measurement of fractional anisotropy of the pyramidal tract A clinical evaluation will be done between Day zero and Day ten then three months, using a neurological score (NIHSS), a score of functional disability (Rankin) and more analytical and sensitive tests such as dynamometer, the Finger Tapping test and test new plugs.
- Conditions
- Ischemic Stroke
- Being tested
- Additional MRI
- Keywords
- Cortical focal atrophy, Stroke, Internal capsule, Corticospinal tract, Wallerian degeneration, Primary motor area.
- Medical subject headings
- Ischemic Stroke, Stroke, Wallerian Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRIOther
| Study group | Role | What they receive |
|---|---|---|
| additional MRI | Other | Not described Receives: Other: Additional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of cortical thickness
Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.
Measured: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.
Secondary outcomes (2)
Calculation of fractional anisotropy
Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
Measured: 3 months after infarction of corticospinal tract
Disability
The disability at 3 months will be evaluated with the Rankin score
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CHOLLET, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862172
- Sponsor's protocol ID
- 12 486 03
- Other IDs
- HAO 2012
- Acronym
- ACFI
- Status last verified
- Feb 2017
- First submitted
- 29 Apr 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ashburner J, Friston K. Multimodal image coregistration and partitioning--a unified framework. Neuroimage. 1997 Oct;6(3):209-17. doi: 10.1006/nimg.1997.0290.
PubMed 9344825Bloch I Fuzzy spatial relationships for image processing and interpretation: a review. Image Vis Comput 2004;23:89-110.
Kolb B. Recovery from early cortical damage in rats. I. Differential behavioral and anatomical effects of frontal lesions at different ages of neural maturation. Behav Brain Res. 1987 Sep;25(3):205-20. doi: 10.1016/0166-4328(87)90069-6.
PubMed 3689568Stinear CM, Barber PA, Smale PR, Coxon JP, Fleming MK, Byblow WD. Functional potential in chronic stroke patients depends on corticospinal tract integrity. Brain. 2007 Jan;130(Pt 1):170-80. doi: 10.1093/brain/awl333.
PubMed 17148468Preul C, Lohmann G, Hund-Georgiadis M, Guthke T, von Cramon DY. Morphometry demonstrates loss of cortical thickness in cerebral microangiopathy. J Neurol. 2005 Apr;252(4):441-7. doi: 10.1007/s00415-005-0671-9. Epub 2005 Feb 23.
PubMed 15726260Tur C, Penny S, Khaleeli Z, Altmann DR, Cipolotti L, Ron M, Thompson AJ, Ciccarelli O. Grey matter damage and overall cognitive impairment in primary progressive multiple sclerosis. Mult Scler. 2011 Nov;17(11):1324-32. doi: 10.1177/1352458511410341. Epub 2011 Jul 29.
PubMed 21803874DeCarli C, Massaro J, Harvey D, Hald J, Tullberg M, Au R, Beiser A, D'Agostino R, Wolf PA. Measures of brain morphology and infarction in the framingham heart study: establishing what is normal. Neurobiol Aging. 2005 Apr;26(4):491-510. doi: 10.1016/j.neurobiolaging.2004.05.004.
PubMed 15653178Fein G, Di Sclafani V, Tanabe J, Cardenas V, Weiner MW, Jagust WJ, Reed BR, Norman D, Schuff N, Kusdra L, Greenfield T, Chui H. Hippocampal and cortical atrophy predict dementia in subcortical ischemic vascular disease. Neurology. 2000 Dec 12;55(11):1626-35. doi: 10.1212/wnl.55.11.1626.
PubMed 11113215Gerloff C, Bushara K, Sailer A, Wassermann EM, Chen R, Matsuoka T, Waldvogel D, Wittenberg GF, Ishii K, Cohen LG, Hallett M. Multimodal imaging of brain reorganization in motor areas of the contralesional hemisphere of well recovered patients after capsular stroke. Brain. 2006 Mar;129(Pt 3):791-808. doi: 10.1093/brain/awh713. Epub 2005 Dec 19.
PubMed 16364955Green HA, Pena A, Price CJ, Warburton EA, Pickard JD, Carpenter TA, Gillard JH. Increased anisotropy in acute stroke: a possible explanation. Stroke. 2002 Jun;33(6):1517-21. doi: 10.1161/01.str.0000016973.80180.7b.
PubMed 12052984Grefkes C, Eickhoff SB, Nowak DA, Dafotakis M, Fink GR. Dynamic intra- and interhemispheric interactions during unilateral and bilateral hand movements assessed with fMRI and DCM. Neuroimage. 2008 Jul 15;41(4):1382-94. doi: 10.1016/j.neuroimage.2008.03.048. Epub 2008 Apr 8.
PubMed 18486490Goldman AL, Pezawas L, Mattay VS, Fischl B, Verchinski BA, Chen Q, Weinberger DR, Meyer-Lindenberg A. Widespread reductions of cortical thickness in schizophrenia and spectrum disorders and evidence of heritability. Arch Gen Psychiatry. 2009 May;66(5):467-77. doi: 10.1001/archgenpsychiatry.2009.24.
PubMed 19414706Jones SE, Buchbinder BR, Aharon I. Three-dimensional mapping of cortical thickness using Laplace's equation. Hum Brain Mapp. 2000 Sep;11(1):12-32. doi: 10.1002/1097-0193(200009)11:13.0.co;2-k.
PubMed 10997850Schaechter JD, Moore CI, Connell BD, Rosen BR, Dijkhuizen RM. Structural and functional plasticity in the somatosensory cortex of chronic stroke patients. Brain. 2006 Oct;129(Pt 10):2722-33. doi: 10.1093/brain/awl214. Epub 2006 Aug 18.
PubMed 16921177Puig J, Pedraza S, Blasco G, Daunis-I-Estadella J, Prats A, Prados F, Boada I, Castellanos M, Sanchez-Gonzalez J, Remollo S, Laguillo G, Quiles AM, Gomez E, Serena J. Wallerian degeneration in the corticospinal tract evaluated by diffusion tensor imaging correlates with motor deficit 30 days after middle cerebral artery ischemic stroke. AJNR Am J Neuroradiol. 2010 Aug;31(7):1324-30. doi: 10.3174/ajnr.A2038. Epub 2010 Mar 18.
PubMed 20299434
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY
- ClinicalTrials.gov ID
- NCT01862172
- Acronym / sponsor ID
- ACFI / 12 486 03
- Conditions
- Ischemic Stroke
- Keywords
- Cortical focal atrophy, Stroke, Internal capsule, Corticospinal tract, Wallerian degeneration, Primary motor area.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 May 2013 (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.
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.
The patient is compared to himself between day zero to ten and three months.
The study hypotheses are:
- A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
- This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
- This atrophy is correlated with disability at three months, assessed by Rankin score.
Detailed description
Twenty-two patients with ischemic stroke, subcortical, involving the internal capsule, will be included.
Each patient will be compared to himself, on day zero to ten and three months.
An MRI will be performed between day zero and ten, then three months of infarction sequences with traditional threeD enabling acquisition and tractography and The measurement of cortical thickness is in mm The measurement of fractional anisotropy of the pyramidal tract A clinical evaluation will be done between Day zero and Day ten then three months, using a neurological score (NIHSS), a score of functional disability (Rankin) and more analytical and sensitive tests such as dynamometer, the Finger Tapping test and test new plugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| additional MRI | Other | Other: Additional MRI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of 18 to 90 years old.
- Subcortical stroke
- Achievement of the internal capsule, according to MRI
- Ability to perform MRI within 10 days after the onset of symptoms
- NIHSS over or equal 2 and < 20
Key exclusion criteria (11 listed)
- Pregnant or nursing women
- Other cerebral lesion, concomitant or preexisting
- Concomitant disease causing unfavorable prognosis within 3 months after inclusion
- pre-existing psychiatric illness
- Alcoholism or other chronic intoxication
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 |
|---|---|---|
| Additional MRI | Other | additional MRI |
Primary outcome
Decrease of cortical thickness
Time frame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.
Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.
2 secondary outcomes
Calculation of fractional anisotropy
Time frame: 3 months after infarction of corticospinal tract
Disability
Time frame: at 3 months
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 23 Feb 2017.
- Background: PubMed 9344825Ashburner J, Friston K. Multimodal image coregistration and partitioning--a unified framework. Neuroimage. 1997 Oct;6(3):209-17. doi: 10.1006/nimg.1997.0290.
- BackgroundBloch I Fuzzy spatial relationships for image processing and interpretation: a review. Image Vis Comput 2004;23:89-110.
- Background: PubMed 3689568Kolb B. Recovery from early cortical damage in rats. I. Differential behavioral and anatomical effects of frontal lesions at different ages of neural maturation. Behav Brain Res. 1987 Sep;25(3):205-20. doi: 10.1016/0166-4328(87)90069-6.
- Background: PubMed 17148468Stinear CM, Barber PA, Smale PR, Coxon JP, Fleming MK, Byblow WD. Functional potential in chronic stroke patients depends on corticospinal tract integrity. Brain. 2007 Jan;130(Pt 1):170-80. doi: 10.1093/brain/awl333.
- Background: PubMed 15726260Preul C, Lohmann G, Hund-Georgiadis M, Guthke T, von Cramon DY. Morphometry demonstrates loss of cortical thickness in cerebral microangiopathy. J Neurol. 2005 Apr;252(4):441-7. doi: 10.1007/s00415-005-0671-9. Epub 2005 Feb 23.
- Background: PubMed 21803874Tur C, Penny S, Khaleeli Z, Altmann DR, Cipolotti L, Ron M, Thompson AJ, Ciccarelli O. Grey matter damage and overall cognitive impairment in primary progressive multiple sclerosis. Mult Scler. 2011 Nov;17(11):1324-32. doi: 10.1177/1352458511410341. Epub 2011 Jul 29.
- Background: PubMed 15653178DeCarli C, Massaro J, Harvey D, Hald J, Tullberg M, Au R, Beiser A, D'Agostino R, Wolf PA. Measures of brain morphology and infarction in the framingham heart study: establishing what is normal. Neurobiol Aging. 2005 Apr;26(4):491-510. doi: 10.1016/j.neurobiolaging.2004.05.004.
- Background: PubMed 11113215Fein G, Di Sclafani V, Tanabe J, Cardenas V, Weiner MW, Jagust WJ, Reed BR, Norman D, Schuff N, Kusdra L, Greenfield T, Chui H. Hippocampal and cortical atrophy predict dementia in subcortical ischemic vascular disease. Neurology. 2000 Dec 12;55(11):1626-35. doi: 10.1212/wnl.55.11.1626.
- Background: PubMed 16364955Gerloff C, Bushara K, Sailer A, Wassermann EM, Chen R, Matsuoka T, Waldvogel D, Wittenberg GF, Ishii K, Cohen LG, Hallett M. Multimodal imaging of brain reorganization in motor areas of the contralesional hemisphere of well recovered patients after capsular stroke. Brain. 2006 Mar;129(Pt 3):791-808. doi: 10.1093/brain/awh713. Epub 2005 Dec 19.
- Background: PubMed 12052984Green HA, Pena A, Price CJ, Warburton EA, Pickard JD, Carpenter TA, Gillard JH. Increased anisotropy in acute stroke: a possible explanation. Stroke. 2002 Jun;33(6):1517-21. doi: 10.1161/01.str.0000016973.80180.7b.
- Background: PubMed 18486490Grefkes C, Eickhoff SB, Nowak DA, Dafotakis M, Fink GR. Dynamic intra- and interhemispheric interactions during unilateral and bilateral hand movements assessed with fMRI and DCM. Neuroimage. 2008 Jul 15;41(4):1382-94. doi: 10.1016/j.neuroimage.2008.03.048. Epub 2008 Apr 8.
- Background: PubMed 19414706Goldman AL, Pezawas L, Mattay VS, Fischl B, Verchinski BA, Chen Q, Weinberger DR, Meyer-Lindenberg A. Widespread reductions of cortical thickness in schizophrenia and spectrum disorders and evidence of heritability. Arch Gen Psychiatry. 2009 May;66(5):467-77. doi: 10.1001/archgenpsychiatry.2009.24.
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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.
François CHOLLET, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional MRI in people with Ischemic Stroke, run by University Hospital, Toulouse at 1 site in France.
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 11 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 23 Feb 2017. 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 France. 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?
Decrease of cortical thickness (time frame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862172, which also lists 37 linked publications.
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 23 Feb 2017.