Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields.
This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.
Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
Hoehn & Yahr Stage I-III (mild to moderate severity).
Aged 45 to 65 years.
Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).
MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.
Significant cognitive impairment (MoCA score < 24) or severe psychiatric symptoms.
History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.
Severe head tremors that would interfere with MRI scanning quality.
Parallel
Temporal Interference Stimulation (130 Hz)
DeviceHigh-frequency sinewave currents (carrier frequency: 2000 Hz and 2130 Hz) are delivered via two pairs of scalp electrodes. The current intensity is 2-4 mA (individualized). In Phase B, stimulation lasts 30 minutes daily for 2 weeks (10 sessions).
Temporal Interference Stimulation (40 Hz)
DeviceHigh-frequency sinewave currents (carrier frequency: 2000 Hz and 2040 Hz) are delivered via two pairs of scalp electrodes. Parameters are identical to the 130 Hz group except for the envelope frequency.
Sham Temporal Interference Stimulation
DeviceThe device provides only a 20-second ramp-up and 20-second ramp-down of current to mimic the skin sensation of active stimulation, without continuous therapeutic stimulation.
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.
Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).
Assessed using resting-state fMRI to quantify the acute and long-term regulatory effects of TIS on the basal ganglia-thalamus-cortical circuit.
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