Targeted temporal interference stimulation of cerebellar nuclei for tremor and walking problems in Parkinson's disease

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

This trial will test whether targeted temporal interference stimulation of the cerebellar nuclei can reduce tremor and improve walking in people with Parkinson's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07384442 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, sham-controlled interventional trial that delivers targeted temporal interference stimulation (TIS) to cerebellar nuclei in people with Parkinson's disease who have tremor and gait disturbance. Participants are randomized to receive real TIS or sham stimulation while remaining on stable medication regimens, and clinical measures of tremor and gait are collected before and after interventions. The protocol enrolls patients aged 50 and older with at least two years since diagnosis, good levodopa response, and the ability to walk independently for testing. The study is conducted at Zhongnan Hospital in Wuhan and compares changes in motor symptoms between the TIS and sham groups to determine whether cerebellar-targeted TIS produces meaningful clinical benefit.

Who should consider this trial

Good fit: Ideal candidates are people aged 50 or older with idiopathic Parkinson's disease of at least two years' duration who have tremor and gait disturbance, a good response to levodopa, stable medications for at least four weeks, and the ability to walk independently for at least five minutes.

Not a fit: Patients with severe psychiatric disorders, major other neurological conditions, inability to walk independently, or who are poor responders to levodopa may be unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this noninvasive neuromodulation approach could reduce tremor severity and improve gait stability, offering an additional treatment option for motor symptoms in Parkinson's disease.

How similar studies have performed: Noninvasive cerebellar stimulation and other neuromodulation methods have produced mixed results in Parkinson's disease, and targeted temporal interference stimulation is a relatively new approach with limited prior clinical data in this population.

Eligibility criteria

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;

Where this trial is running

Wuhan, Hubei

• Zhongnan hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Yang Pan

Conditions: Parkinson's Disease, Movement Disorders, Cerebellar Nuclei, Tremor, Gait, Temporal Interference Stimulation