Actively Recruiting
Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
Led by YangPan · Updated on 2026-03-23
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of targeted temporal interference stimulation (TIS) of the cerebellar nuclei on tremor and gait problems in patients with Parkinson's disease (PD). This trial compares the benefits of real TIS versus sham stimulation in improving these motor symptoms by precisely modulating cerebellar neural circuits. Parkinson's disease is a common movement disorder marked by tremors, muscle stiffness, and difficulty walking, caused by the loss of dopamine-producing brain cells. Recent research suggests the cerebellum plays a key role in these symptoms, making it a target for this intervention. Participants will be randomly assigned to receive either real TIS or sham (placebo) stimulation targeting the cerebellar nuclei. Both groups will undergo daily sessions of 40 minutes (20 minutes per side) for 5 days followed by 2 days off, repeated over 19 days. Real TIS uses a 100 Hz frequency with currents adjusted to individual tolerance, while sham TIS uses 0 Hz to prevent stimulation effects. This non-invasive device-based approach aims to directly influence brain areas controlling movement. Throughout the study, participants will be assessed using the Unified Parkinson Disease Rating Scale (UPDRS), a specialized gait analysis device, and electromyography to measure tremors. These evaluations will take place before treatment, immediately after the 19-day treatment, and at a 30-day follow-up. Researchers will analyze changes in tremor severity and gait function to determine if TIS improves motor symptoms. The total duration of participation includes treatment and follow-up periods, with ongoing monitoring to ensure safety and measure outcomes.
CONDITIONS
Brief Title
Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years or older
- Confirmed diagnosis of idiopathic Parkinson's disease with tremor and gait disturbance
- Disease duration of 2 years or more with stable condition
- Stable medication dosage for at least 4 weeks before the trial
- Good response to Levodopa therapy
- Able to walk independently for at least 5 minutes without assistive devices
- Signed informed consent and able to understand study participation
You will not qualify if you...
- History or diagnosis of severe mental disorders such as depression, anxiety, schizophrenia, or bipolar disorder
- Neurological conditions like increased intracranial pressure, stroke, TIA within 2 years, cerebral aneurysm, dementia, or multiple sclerosis
- Severe cognitive impairment with MMSE score below 22 or inability to complete questionnaires
- Inability to read or understand Chinese
- Use of other neuromodulatory therapies in the past 3 months
- Musculoskeletal or orthopedic issues significantly affecting gait or balance
- Presence of metal implants like deep brain stimulators or pacemakers, or contraindications for MRI/TIS
- Current use of medications affecting dopamine levels, such as antipsychotics
- Severe cardiovascular or other unstable medical conditions preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 19 days
Participants receive targeted temporal interference stimulation (TIS) or sham stimulation of the cerebellar nuclei. Stimulation is applied daily for 20 minutes on each side of the cerebellum, followed by rest periods, repeated continuously for 19 days.
Daily visits for up to 19 days
Duration - 30 days
Participants are assessed to evaluate changes in tremor and gait after completing the treatment phase.
1 visit (in-person) at 30 days post-treatment
Trial Site Locations
Total: 1 location
1
Zhongnan hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Y
Yang Pan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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