Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorYangPan

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sham Temporal Interference Stimulation
  • Real Temporal Interference Stimulation

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1
Zhongnan hospital430000, WuhanHubei, China

Sponsors and collaborators

YangPan

Lead sponsor

Zhongnan Hospital

Sponsor institution