NCT07384442

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: YangPan · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Parkinson's disease (PD) is a neurodegenerative disorder with an extremely high global incidence rate and is also one of the most common movement disorders. The core motor symptoms of this disease are particularly complex, encompassing various specific clinical features, including bradykinesia, resting tremor, muscle rigidity, and postural and gait disturbances. The progressive worsening of these symptoms is closely associated with the gradual loss of dopaminergic neurons in the substantia nigra-striatal pathway of the brain, which directly leads to significant impairment of motor control function. In recent years, with the continuous advancement of neuroimaging techniques and electrophysiological research methods, scientists have gradually revealed the critical role of the cerebellum in the pathophysiological mechanisms of Parkinson's disease. Studies have shown that the cerebellum is not only a key node in the motor control network but also deeply involved in the pathogenesis of PD tremor through the thalamocortical circuit. Additionally, the cerebellum plays an indispensable role in regulating gait stability through functional connections with the basal ganglia and cerebral cortex. Based on the dual role of the cerebellum in the pathophysiological processes of Parkinson's disease, this study plans to employ an innovative technical approach-targeted temporal interference stimulation (TIS) of cerebellar nuclei-to precisely modulate the activity of cerebellar neural circuits in a non-invasive manner. The cerebellar nuclei are located deep within the white matter of the cerebellum and can be further subdivided into the dentate nucleus, intercalated nucleus, and vermis, which exhibit distinct differences from the cerebellar cortex. As the core output hub of the entire cerebellum, all signals originating from the cerebellar cortex ultimately converge here before being projected to the cerebral cortex, brainstem, and spinal cord, regulating motor coordination, gait, balance, muscle tone, and tremors. Transcranial induction stimulation (TIS) non-invasively modulates the intact cerebellar nuclei, enabling direct regulation of cerebellar function, which is more efficient compared to modulating the cerebellar cortex. The objective of this intervention approach is to validate its efficacy in improving tremor and gait disorders in patients with Parkinson's disease (PD), thereby providing a novel neuromodulatory strategy for the clinical treatment of motor symptoms in PD and further expanding our understanding and application scope of therapeutic approaches for this disorder. To explore the effect of TIS targeting cerebellar nuclei on tremor and gait disorders in PD patients. Participants will be assigned to group active TIS/sham TIS by using the method of generating random numbers and receive: 1. Unified Parkinson Disease Rating Scale (UPDRS) before and after the treatment course. 2. Zhenluo Gait Device evaluation. 3. Electromyography tremor assessment Researchers will compare the data collected from UPDRS, Zhenluo Gait Device analysis, and electromyography tremor assessment rating between the active TIS group and sham controls before and after the treatment to see if there are meliorating effects of TIS on Parkinson's disease.

Conditions

• Parkinson's Disease
• Movement Disorders

Interventions

Type	Name	Description
DEVICE	Sham Temporal Interference Stimulation	Patients 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.
DEVICE	Real Temporal Interference Stimulation	Patients 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.

Timeline

• Start date: 2026-03-19
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-03
• Last updated: 2026-03-23

Locations

1 site across 1 country: China