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Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
RECRUITINGN/ASponsored by YangPan
Actively Recruiting
PhaseN/A
SponsorYangPan
Started2026-03-19
Est. completion2026-12-31
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07384442
Summary
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.
Eligibility
Age: 50 Years+Healthy volunteers accepted
Inclusion Criteria: * 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; * 5.Good response to Levodopa therapy; * 6.Capable of independent walking (without assistive devices) for at least 5 minutes and able to complete gait testing independently. * 7.Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study. Exclusion Criteria: * 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; * 5.Use of other neuromodulatory therapies within the past 3 months; * 6.Presence of musculoskeletal or orthopedic conditions (e.g., severe arthritis, recent fractures) that significantly interfere with gait or balance; * 7.Presence of metal implants (e.g., Deep Brain Stimulation, cardiac pacemakers) or contraindications for MRI/TIS; * 8.Current use of medications that affect dopamine levels (e.g., antipsychotics); * 9.Severe cardiovascular disease or other unstable medical conditions that preclude physical exertion or study participation;
Conditions2
Movement DisordersParkinson's Disease
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Actively Recruiting
PhaseN/A
SponsorYangPan
Started2026-03-19
Est. completion2026-12-31
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07384442