Research Center of Neurology, Russia — Biomedical Watch V2

Traitements4programmes

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Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Combined MR-guided Focused Ultrasound PTT and VIM TreatmentThis study is evaluating MR-guided Focused Ultrasound (MRgFUS) treatment for people with Parkinson's disease (PD) who have disabling tremor, bradykinesia, and rigidity despite optimal medical therapy. The study uses the Exablate Neuro System, which delivers ultrasound energy on a specific brain target and generates a small lesion (ablation) without making a surgical incision. This study evaluates three treatment approaches targeting different brain structures involved in Parkinson's motor symptoms: * Pallidothalamic Tractotomy (PTT): targeting pathways connecting the globus pallidus to the thalamus and subthalamic region structures. * Thalamotomy (VIM): targeting the ventral intermediate nucleus of the thalamus, a structure involved in pathogenesis of tremor. * Combined PTT+VIM: targeting both structures during a single treatment procedure. Participants will be randomly assigned to one of four groups: PTT, VIM, PTT+VIM, or "delayed treatment". Participants in the delayed-treatment group will continue best medical therapy for 6 months before receiving MRgFUS treatment. The study aims to determine whether PTT provides greater improvement in motor symptoms than optimized medical therapy alone, whether adding VIM treatment to PTT improves tremor control, and whether adding PTT to VIM treatment provides additional improvement in bradykinesia and rigidity. The main outcome measures are changes in the MDS-UPDRS Part III motor scores: 1. Overall motor symptoms: change in the contralateral body-side MDS-UPDRS Part III motor score at 6 months after randomization, comparing PTT with delayed treatment. 2. Tremor: change in the contralateral tremor score at 6, 12 months after treatment, comparing PTT+VIM with PTT alone. 3. Bradykinesia and rigidity: change in the contralateral bradykinesia and rigidity score at 6, 12 months after treatment, comparing PTT+VIM with VIM alone. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld to better evaluate the treatment effect. In addition, changes in motor complications, tremor severity, quality of life, and medication requirements will be assessed using MDS-UPDRS Parts II-IV, the Clinical Rating Scale for Tremor (CRST), the Parkinson's Disease Questionnaire (PDQ-39), and levodopa equivalent daily dose (LEDD). Treatment-related adverse events, cognitive function, and ablation spot characteristics will also be evaluated throughout follow-up.	Parkinson	Non applicable	Traitement symptomatique	Russia	À vérifier
MR-guided Focused Ultrasound Pallidothalamic TractotomyThis study is evaluating MR-guided Focused Ultrasound (MRgFUS) treatment for people with Parkinson's disease (PD) who have disabling tremor, bradykinesia, and rigidity despite optimal medical therapy. The study uses the Exablate Neuro System, which delivers ultrasound energy on a specific brain target and generates a small lesion (ablation) without making a surgical incision. This study evaluates three treatment approaches targeting different brain structures involved in Parkinson's motor symptoms: * Pallidothalamic Tractotomy (PTT): targeting pathways connecting the globus pallidus to the thalamus and subthalamic region structures. * Thalamotomy (VIM): targeting the ventral intermediate nucleus of the thalamus, a structure involved in pathogenesis of tremor. * Combined PTT+VIM: targeting both structures during a single treatment procedure. Participants will be randomly assigned to one of four groups: PTT, VIM, PTT+VIM, or "delayed treatment". Participants in the delayed-treatment group will continue best medical therapy for 6 months before receiving MRgFUS treatment. The study aims to determine whether PTT provides greater improvement in motor symptoms than optimized medical therapy alone, whether adding VIM treatment to PTT improves tremor control, and whether adding PTT to VIM treatment provides additional improvement in bradykinesia and rigidity. The main outcome measures are changes in the MDS-UPDRS Part III motor scores: 1. Overall motor symptoms: change in the contralateral body-side MDS-UPDRS Part III motor score at 6 months after randomization, comparing PTT with delayed treatment. 2. Tremor: change in the contralateral tremor score at 6, 12 months after treatment, comparing PTT+VIM with PTT alone. 3. Bradykinesia and rigidity: change in the contralateral bradykinesia and rigidity score at 6, 12 months after treatment, comparing PTT+VIM with VIM alone. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld to better evaluate the treatment effect. In addition, changes in motor complications, tremor severity, quality of life, and medication requirements will be assessed using MDS-UPDRS Parts II-IV, the Clinical Rating Scale for Tremor (CRST), the Parkinson's Disease Questionnaire (PDQ-39), and levodopa equivalent daily dose (LEDD). Treatment-related adverse events, cognitive function, and ablation spot characteristics will also be evaluated throughout follow-up.	Parkinson	Non applicable	Traitement symptomatique	Russia	À vérifier
MR-guided Focused Ultrasound VIM ThalamotomyThis study is evaluating MR-guided Focused Ultrasound (MRgFUS) treatment for people with Parkinson's disease (PD) who have disabling tremor, bradykinesia, and rigidity despite optimal medical therapy. The study uses the Exablate Neuro System, which delivers ultrasound energy on a specific brain target and generates a small lesion (ablation) without making a surgical incision. This study evaluates three treatment approaches targeting different brain structures involved in Parkinson's motor symptoms: * Pallidothalamic Tractotomy (PTT): targeting pathways connecting the globus pallidus to the thalamus and subthalamic region structures. * Thalamotomy (VIM): targeting the ventral intermediate nucleus of the thalamus, a structure involved in pathogenesis of tremor. * Combined PTT+VIM: targeting both structures during a single treatment procedure. Participants will be randomly assigned to one of four groups: PTT, VIM, PTT+VIM, or "delayed treatment". Participants in the delayed-treatment group will continue best medical therapy for 6 months before receiving MRgFUS treatment. The study aims to determine whether PTT provides greater improvement in motor symptoms than optimized medical therapy alone, whether adding VIM treatment to PTT improves tremor control, and whether adding PTT to VIM treatment provides additional improvement in bradykinesia and rigidity. The main outcome measures are changes in the MDS-UPDRS Part III motor scores: 1. Overall motor symptoms: change in the contralateral body-side MDS-UPDRS Part III motor score at 6 months after randomization, comparing PTT with delayed treatment. 2. Tremor: change in the contralateral tremor score at 6, 12 months after treatment, comparing PTT+VIM with PTT alone. 3. Bradykinesia and rigidity: change in the contralateral bradykinesia and rigidity score at 6, 12 months after treatment, comparing PTT+VIM with VIM alone. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld to better evaluate the treatment effect. In addition, changes in motor complications, tremor severity, quality of life, and medication requirements will be assessed using MDS-UPDRS Parts II-IV, the Clinical Rating Scale for Tremor (CRST), the Parkinson's Disease Questionnaire (PDQ-39), and levodopa equivalent daily dose (LEDD). Treatment-related adverse events, cognitive function, and ablation spot characteristics will also be evaluated throughout follow-up.	Parkinson	Non applicable	Traitement symptomatique	Russia	À vérifier
MR-guided Focused Ultrasound Pallidothalamic TractotomyThis study is evaluating MR-guided Focused Ultrasound (MRgFUS) treatment for people with Parkinson's disease (PD) who have disabling tremor, bradykinesia, and rigidity despite optimal medical therapy. The study uses the Exablate Neuro System, which delivers ultrasound energy on a specific brain target and generates a small lesion (ablation) without making a surgical incision. This study evaluates three treatment approaches targeting different brain structures involved in Parkinson's motor symptoms: * Pallidothalamic Tractotomy (PTT): targeting pathways connecting the globus pallidus to the thalamus and subthalamic region structures. * Thalamotomy (VIM): targeting the ventral intermediate nucleus of the thalamus, a structure involved in pathogenesis of tremor. * Combined PTT+VIM: targeting both structures during a single treatment procedure. Participants will be randomly assigned to one of four groups: PTT, VIM, PTT+VIM, or "delayed treatment". Participants in the delayed-treatment group will continue best medical therapy for 6 months before receiving MRgFUS treatment. The study aims to determine whether PTT provides greater improvement in motor symptoms than optimized medical therapy alone, whether adding VIM treatment to PTT improves tremor control, and whether adding PTT to VIM treatment provides additional improvement in bradykinesia and rigidity. The main outcome measures are changes in the MDS-UPDRS Part III motor scores: 1. Overall motor symptoms: change in the contralateral body-side MDS-UPDRS Part III motor score at 6 months after randomization, comparing PTT with delayed treatment. 2. Tremor: change in the contralateral tremor score at 6, 12 months after treatment, comparing PTT+VIM with PTT alone. 3. Bradykinesia and rigidity: change in the contralateral bradykinesia and rigidity score at 6, 12 months after treatment, comparing PTT+VIM with VIM alone. MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld to better evaluate the treatment effect. In addition, changes in motor complications, tremor severity, quality of life, and medication requirements will be assessed using MDS-UPDRS Parts II-IV, the Clinical Rating Scale for Tremor (CRST), the Parkinson's Disease Questionnaire (PDQ-39), and levodopa equivalent daily dose (LEDD). Treatment-related adverse events, cognitive function, and ablation spot characteristics will also be evaluated throughout follow-up.	Parkinson	Non applicable	Traitement symptomatique	Russia	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
MR-guided Focused Ultrasound Pallidothalamic Tractotomy	Parkinson	Non applicable	NCT07925086	FOREL-PD — Magnetic-Resonance Guided Focused Ultrasound Pallidothalamic Tractotomy for Parkinson's Disease	NOT_YET_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.