MRI-Guided Temporal Interference Stimulation for Parkinson's Disease
ConditionParkinson Disease (PD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later. The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years (inclusive), any gender.
Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
Disqualifiers
Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
A history of psychiatric disorders or current severe depression or anxiety;
Trial design
Design model
Parallel
Treatments tested in this trial
Temporal Interference Stimulation (130 Hz)
DeviceAll participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus. The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation. Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Experimental group AActive comparator 1 intervention
Group B: Experimental group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.
Time frame
at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulationOther outcomes
1
The incidence of SAE
The incidence of SAE
Time frame
From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 3 weeks). SAEs will be monitored and recorded continuously throughout this period.2
All-cause mortality
All-cause mortality
Time frame
1month after randomizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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