Parc de Salut Mar — Biomedical Watch V2

Traitements6programmes

Essais2liés

Publications2liées

SourceDBlocale

Traitements

6

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
[18F]fluorodeprenyl-D2Despite significant advancements in multiple sclerosis (MS) treatment over the past decade, a specific imaging biomarker for predicting disease progression remains lacking. This project is conducted as a non-therapeutic clinical trial with an investigational medicinal product and aims to validate PET imaging with the radiotracer \[18F\]fluorodeprenyl-D2 (\[18F\]F-DED) as a diagnostic tool for detecting chronic active lesions in MS and to evaluate its potential as a predictor of disease progression. Chronic astrocyte activation plays a key role in MS pathology, yet current imaging techniques, such as MRI, have limited sensitivity in identifying chronic neuroinflammation. By leveraging PET imaging with \[18F\]F-DED, which specifically targets activated astrocytes, this study seeks to provide a more precise assessment of chronic inflammatory lesions in MS patients. The project will follow a cross-sectional and longitudinal design: O1) To validate the ability of \[18F\]F-DED PET to identify chronic active lesions by comparing PET findings with MRI markers, including paramagnetic rings (PRLs) and determine its diagnostic accuracy; O2) To explore the relationship between astrocyte-targeted PET imaging and blood-based biomarkers of astrogliosis ; O3) To assess the predictive value of PET-detected chronic inflammation in disease progression over a three-year follow-up period through regression analysis, integrating clinical parameters such as disability progression (EDSS scores), relapse rates, and MRI changes. A total of 30 MS patients will be recruited from the MS Unit of Hospital del Mar and undergo PET and MRI imaging, following a single intravenous administration of the investigational radiotracer \[18F\]F-DED, together with MRI imaging with advanced image fusion techniques ensuring precise lesion localization. Machine learning models will be applied to imaging and clinical data to identify biomarkers associated with MS progression. By improving diagnostic accuracy and predicting disease evolution, this clinical trial aims to enhance patient stratification and treatment personalization.	SEP	Non applicable	Ralentissement de la progression	Spain	À vérifier
ARM B: Sham-radial shock Wave therapyThe goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.	Accident vasculaire cérébral	Phase 1	Traitement symptomatique	Spain	À vérifier
Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar).The goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.	Accident vasculaire cérébral	Phase 1	Traitement symptomatique	Spain	À vérifier
Ultrasound-guided abobotulinumtoxin AThe goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.	Accident vasculaire cérébral	Phase 1	Traitement symptomatique	Spain	À vérifier
[18F]fluorodeprenyl-D2Despite significant advancements in multiple sclerosis (MS) treatment over the past decade, a specific imaging biomarker for predicting disease progression remains lacking. This project is conducted as a non-therapeutic clinical trial with an investigational medicinal product and aims to validate PET imaging with the radiotracer \[18F\]fluorodeprenyl-D2 (\[18F\]F-DED) as a diagnostic tool for detecting chronic active lesions in MS and to evaluate its potential as a predictor of disease progression. Chronic astrocyte activation plays a key role in MS pathology, yet current imaging techniques, such as MRI, have limited sensitivity in identifying chronic neuroinflammation. By leveraging PET imaging with \[18F\]F-DED, which specifically targets activated astrocytes, this study seeks to provide a more precise assessment of chronic inflammatory lesions in MS patients. The project will follow a cross-sectional and longitudinal design: O1) To validate the ability of \[18F\]F-DED PET to identify chronic active lesions by comparing PET findings with MRI markers, including paramagnetic rings (PRLs) and determine its diagnostic accuracy; O2) To explore the relationship between astrocyte-targeted PET imaging and blood-based biomarkers of astrogliosis ; O3) To assess the predictive value of PET-detected chronic inflammation in disease progression over a three-year follow-up period through regression analysis, integrating clinical parameters such as disability progression (EDSS scores), relapse rates, and MRI changes. A total of 30 MS patients will be recruited from the MS Unit of Hospital del Mar and undergo PET and MRI imaging, following a single intravenous administration of the investigational radiotracer \[18F\]F-DED, together with MRI imaging with advanced image fusion techniques ensuring precise lesion localization. Machine learning models will be applied to imaging and clinical data to identify biomarkers associated with MS progression. By improving diagnostic accuracy and predicting disease evolution, this clinical trial aims to enhance patient stratification and treatment personalization.	SEP	Non applicable	Ralentissement de la progression	Spain	À vérifier
Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar).The goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.	Accident vasculaire cérébral	Phase 1	Traitement symptomatique	Spain	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar).	Accident vasculaire cérébral	Phase 1	NCT07875868	Radial Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Type A for Post-Stroke Lower Limb Spasticity (SOLUTION)	COMPLETED
[18F]fluorodeprenyl-D2	SEP	Non applicable	NCT07805473	F-DED PET MS — [18F]F-DED PET Imaging of Reactive Astrocytes in Multiple Sclerosis	NOT_YET_RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
[18F]fluorodeprenyl-D2		[18F]fluorodeprenyl-D2 PET can detect and monitor astrogliosis in anti-LGI1-IgG autoimmune encephalitis.	European journal of nuclear medicine and molecular imaging
[18F]fluorodeprenyl-D2		[F]Fluorodeprenyl-D2 PET as a Tool to Monitor Disease Activity in GAD65-Ab Autoimmune Encephalitis.	Annals of clinical and translational neurology