The goal of this clinical trial is to explore the effects of cerebellar nuclei TIS stimulation on improving tremor and gait disorders in PD patients. Through randomized double-blind grouping, the differences in efficacy between TIS intervention and sham stimulation intervention for tremor and gait disorders in PD patients will be compared.
1.Aged 50 years or older;
2.Confirmed diagnosis of idiopathic Parkinson's disease (IPD) according to the 2015 MDS diagnostic criteria, with tremor and gait disturbance;
3.Disease duration ≥2 years after diagnosis, stable condition, and ability to cooperate with study assessment and intervention;
4.Stable medication dosage for at least 4 weeks prior to the trial;
1.History or confirmed diagnosis of severe mental disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorder;
2.The subject has clinically defined neurological conditions (assessed through self-report), including but not limited to: any disease potentially associated with increased intracranial pressure, space-occupying lesions, stroke history, transient ischemic attack (TIA) within the past two years, cerebral aneurysm, dementia, multiple sclerosis;
3.Severe cognitive impairment, Mini-Mental State Examination (MMSE) score <22, or inability to independently complete questionnaires;
4.Inability to read or understand Chinese;
Parallel
Sham Temporal Interference Stimulation
DevicePatients will be randomly allocated into this group, and they will receive sham TIS-targeted stimulation of cerebellar nuclei, stimulating both sides of the cerebellum daily for 20 minutes each side. Start with the left side, immediately followed by the right side upon completion, totaling 40 minutes of stimulation. Continue this cycle for 5 days, followed by 2 days of rest, then repeat for another 5 days, repeating this process continuously for 19 days.The TIS frequency was set to 0 Hz to prevent the generation of envelope currents.
Real Temporal Interference Stimulation
DevicePatients will be randomly allocated into this group, and they will receive real stimulation.TIS-targeted stimulation of cerebellar nuclei, stimulating both sides of the cerebellum daily for 20 minutes each side. Start with the left side, immediately followed by the right side upon completion, totaling 40 minutes of stimulation. Continue this cycle for 5 days, followed by 2 days of rest, then repeat for another 5 days, repeating this process continuously for 19 days. The TIS was set at a frequency of 100 Hz; The stimulus frequency difference was fixed for each subject, while the stimulus current was adjusted based on individual tolerance and clinical needs.
Changes of electromyographic tremor index
The values of the tremor amplitude (oscillatory displacement) will be collected from each participant to measure the intensity of the tremor with values ranging from 0 mm (absence of tremor) to the peak amplitude (maximum intensity). The higher values mean a worse motor stability.
Changes of Zhenluo Gait Device evaluation
The parameters of the Zhenluo Gait Device evaluation (spatiotemporal gait analysis) will be collected from each participant to measure the stability and quality of walking patterns with values ranging from pathological (abnormal deviation) to physiological (normal gait). The greater deviation from normative data means a worse gait performance.
Changes in the scores of the UPDRS
The UPDRS (total) score will be collected from each participant to measure the overall severity of Parkinson's disease, with scores ranging from 0 (minimum) to 199 (maximum). The higher scores mean a worse outcome.
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YangPan
Lead sponsor
Zhongnan Hospital
Sponsor institution
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