Zhongnan Hospital — Biomedical Watch V2

Traitements3programmes

Essais1liés

Publications0liées

SourceDBlocale

Traitements

3

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
TIS-GPThis prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in patients with Parkinson's disease (PD). Eighteen participants with idiopathic PD will be randomly assigned in a 1:1 ratio to the STN-TIS or GPi-TIS group. Participants will receive one 20-minute TIS session daily for 7 consecutive days. Motor symptoms will be assessed using the MDS-UPDRS Part III immediately before and after each daily stimulation session. Resting-state functional magnetic resonance imaging (fMRI) and 64-channel electroencephalography (EEG) will be performed before the first stimulation session and immediately after completion of the 7-day intervention. The primary outcomes are: (1) change in MDS-UPDRS Part III score from Day 1 before stimulation to Day 7 after stimulation; and (2) changes in regional spontaneous brain activity and seed-based functional connectivity measured using resting-state fMRI. Secondary outcomes are: (1) daily immediate changes in MDS-UPDRS Part III scores and the proportion of participants achieving at least 30% improvement at Day 7; and (2) changes in resting-state 64-channel EEG relative bandpower. Safety and tolerability will be evaluated by monitoring adverse events and local skin reactions throughout the intervention. This study aims to provide preliminary evidence regarding target-dependent functional response patterns associated with STN- and GPi-targeted TIS in PD.	Parkinson	Non applicable	Traitement symptomatique	China	À vérifier
TIS-STNThis prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in patients with Parkinson's disease (PD). Eighteen participants with idiopathic PD will be randomly assigned in a 1:1 ratio to the STN-TIS or GPi-TIS group. Participants will receive one 20-minute TIS session daily for 7 consecutive days. Motor symptoms will be assessed using the MDS-UPDRS Part III immediately before and after each daily stimulation session. Resting-state functional magnetic resonance imaging (fMRI) and 64-channel electroencephalography (EEG) will be performed before the first stimulation session and immediately after completion of the 7-day intervention. The primary outcomes are: (1) change in MDS-UPDRS Part III score from Day 1 before stimulation to Day 7 after stimulation; and (2) changes in regional spontaneous brain activity and seed-based functional connectivity measured using resting-state fMRI. Secondary outcomes are: (1) daily immediate changes in MDS-UPDRS Part III scores and the proportion of participants achieving at least 30% improvement at Day 7; and (2) changes in resting-state 64-channel EEG relative bandpower. Safety and tolerability will be evaluated by monitoring adverse events and local skin reactions throughout the intervention. This study aims to provide preliminary evidence regarding target-dependent functional response patterns associated with STN- and GPi-targeted TIS in PD.	Parkinson	Non applicable	Traitement symptomatique	China	À vérifier
TIS-STNThis prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in patients with Parkinson's disease (PD). Eighteen participants with idiopathic PD will be randomly assigned in a 1:1 ratio to the STN-TIS or GPi-TIS group. Participants will receive one 20-minute TIS session daily for 7 consecutive days. Motor symptoms will be assessed using the MDS-UPDRS Part III immediately before and after each daily stimulation session. Resting-state functional magnetic resonance imaging (fMRI) and 64-channel electroencephalography (EEG) will be performed before the first stimulation session and immediately after completion of the 7-day intervention. The primary outcomes are: (1) change in MDS-UPDRS Part III score from Day 1 before stimulation to Day 7 after stimulation; and (2) changes in regional spontaneous brain activity and seed-based functional connectivity measured using resting-state fMRI. Secondary outcomes are: (1) daily immediate changes in MDS-UPDRS Part III scores and the proportion of participants achieving at least 30% improvement at Day 7; and (2) changes in resting-state 64-channel EEG relative bandpower. Safety and tolerability will be evaluated by monitoring adverse events and local skin reactions throughout the intervention. This study aims to provide preliminary evidence regarding target-dependent functional response patterns associated with STN- and GPi-targeted TIS in PD.	Parkinson	Non applicable	Traitement symptomatique	China	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
TIS-STN	Parkinson	Non applicable	NCT07745673	tTIS — Comparative Study of TIS Efficacy Across Different Targets	RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.