The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NCT Number: NCT07572903
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Temporal Interference Stimulation
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
CGI comprehensively quantifies the severity of a patient's illness and the net benefit of treatment by assessing disease severity (CGI-S), overall improvement (CGI-I), and the balance between efficacy and side effects (Efficacy Index EI).
Time frame: Baseline,Immediately after a single stimulation
Time frame: Baseline,Immediately after a single stimulation
Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity.
The First Affiliated Hospital of Anhui Medical University
Other
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
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