An interventional study of Multi-b diffusion sequence MRI in Stroke, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
This study will include 100 stroke patients with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously. Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system. In this project the investigators hypothesize that diffusion MRI at high and ultra-high b-values could be sensitive enough to quantify selective neuronal loss in the rescued penumbra and to study its relationship with the initial hypoperfusion and its impact in terms of clinical recovery.
Thrombectomy has significantly improved the outcome of stroke patients. However, even after successful recanalization residual handicap including post-stroke cognitive and mood disorders impact the quality of life of patients. These symptoms correlate only moderately with the final stroke volume suggesting more widespread dysfunction than what is apparent on standard follow-up MRI. One hypothesis is that the rescued penumbra (i.e.; the tissue showing significant hypoperfusion at the acute stage but that appears normal on conventional imaging at follow up) could exhibit incomplete ischemic injury also known under the term of selective neuronal loss. The concept of selective neuronal loss in the rescued penumbra is admitted based on histological, animal and PET studies but the identification of such a graduation between pan-necrosis and normal tissue is very challenging to capture in vivo with MRI and is typically missed.
This study will prospectively include 100 stroke patients. Patients admitted with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy thrombolysis or spontaneously will be explored at 24h-to-72h and then at 3 months with the multi-b diffusion sequence. The investigators expect to be able to measure significant modifications within the rescued penumbra as compared to contralateral normal brain by using the advanced but also the simplified diffusion metrics. Investigators will test the impact of duration/severity of the initial hypoperfusion and they will explore the clinical relevance especially in terms of cognitive and mood disorders as measured at 3 months.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Exclusion Criteria:
For stroke patients, the follow-up MRI (named MRI-2) after successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously, will be performed between 24h and 72h after recanalization on our new Canon 3T research magnet with high gradient system. Patients will be explored for a follow-up evaluation at 3 months with a final MRI (named MRI-3) that will be performed on the Canon 3T research magnet.
Device: Multi-b diffusion sequence MRI
Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.
Mean Diffusivity (MD) (in 10-9 m2/s)
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain
Time frame: Up to 72 hours
Mean Diffusivity (MD) (in 10-9 m2/s)
Computation of Mean Diffusivity (MD) metrics (in 10-9 m2/s) including MDlow for b=1000s/mm2 and pseudo-MDhigh for maps calculated from the highest b-values within the rescued penumbra and within normal contralateral symmetric region of the brain
Time frame: 3 month of follow-up.
Mean Kurtosis (MK)
Average of the diffusional kurtosis along all diffusion directions
Time frame: Up to 72 hours
Mean Kurtosis (MK)
Average of the diffusional kurtosis along all diffusion directions
Time frame: 3 month of follow-up
Mean Diffusivity of the slow component (MDs)
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Time frame: Up to 72 hours
Mean Diffusivity of the slow component (MDs)
Mean Diffusivity of the slow component (MDs) within the rescued penumbra and within normal contralateral symmetric region
Time frame: 3 month of follow-up
Magnetization Transfert Ratio
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain
Time frame: Up to 72 hours
Magnetization Transfert Ratio
Magnetization Transfert Ratio maps (MTR=(0-Ms)/M0 x100 where M0 and Ms represent the signal intensity with the saturation prepulse off and on, respectively) within the rescued penumbra and within normal contralateral symmetric region of the brain
Time frame: 3 month of follow-up
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux