Parkinson's DiseaseNCT07384442
Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
A study testing Real Temporal Interference Stimulation in people with Parkinson's Disease and Movement Disorders, run by YangPan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease, Movement Disorders
- What is being tested?
- Real Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan hospital
Wuhan, Hubei, 430000
Yang Pan, Chief Physician, 0258-2263671, neuro_panyang@163.com
About this study
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.
Read the 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:
- Unified Parkinson Disease Rating Scale (UPDRS) before and after the treatment course.
- Zhenluo Gait Device evaluation.
- 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
- Being tested
- Sham Temporal Interference Stimulation, Real Temporal Interference Stimulation
- Keywords
- Parkinson's Disease, Cerebellar Nuclei, Movement Disorders, Tremor, Gait, Temporal Interference Stimulation
- Medical subject headings
- Parkinson Disease, Movement Disorders, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Temporal Interference StimulationDevice
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.
Real Temporal Interference StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator | Sham comparator | Sham stimulation targeting the cerebellar nuclei Receives: Device: Sham Temporal Interference Stimulation |
| Active Comparator | Active comparator | Real TIS targeting the cerebellar nuclei Receives: Device: Real Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of electromyographic tremor index
The values of the tremor amplitude (oscillatory displacement) will be collected from each participant to measure the intensity of the tremor with values ranging from 0 mm (absence of tremor) to the peak amplitude (maximum intensity). The higher values mean a worse motor stability.
Measured: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
Changes of Zhenluo Gait Device evaluation
The parameters of the Zhenluo Gait Device evaluation (spatiotemporal gait analysis) will be collected from each participant to measure the stability and quality of walking patterns with values ranging from pathological (abnormal deviation) to physiological (normal gait). The greater deviation from normative data means a worse gait performance.
Measured: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
Secondary outcomes (1)
Changes in the scores of the UPDRS
The UPDRS (total) score will be collected from each participant to measure the overall severity of Parkinson's disease, with scores ranging from 0 (minimum) to 199 (maximum). The higher scores mean a worse outcome.
Measured: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start19 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YangPan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YangPan, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384442
- Sponsor's protocol ID
- 2026022
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT07384442
- Acronym / sponsor ID
- 2026022
- Conditions
- Parkinson's Disease, Movement Disorders
- Keywords
- Parkinson's Disease, Cerebellar Nuclei, Movement Disorders, Tremor, Gait, Temporal Interference Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- YangPanUniversity, hospital or other
- Study start
- 19 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Unified Parkinson Disease Rating Scale (UPDRS) before and after the treatment course.
- Zhenluo Gait Device evaluation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator | Sham comparator | Device: Sham Temporal Interference StimulationSham stimulation targeting the cerebellar nuclei |
| Active Comparator | Active comparator | Device: Real Temporal Interference StimulationReal TIS targeting the cerebellar nuclei |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Temporal Interference StimulationPatients 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 | Sham Comparator |
| Real Temporal Interference StimulationPatients 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. | Device | Active Comparator |
Primary outcome
Changes of electromyographic tremor index
Time frame: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
The values of the tremor amplitude (oscillatory displacement) will be collected from each participant to measure the intensity of the tremor with values ranging from 0 mm (absence of tremor) to the peak amplitude (maximum intensity). The higher values mean a worse motor stability.
Changes of Zhenluo Gait Device evaluation
Time frame: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
The parameters of the Zhenluo Gait Device evaluation (spatiotemporal gait analysis) will be collected from each participant to measure the stability and quality of walking patterns with values ranging from pathological (abnormal deviation) to physiological (normal gait). The greater deviation from normative data means a worse gait performance.
1 secondary outcome
Changes in the scores of the UPDRS
Time frame: Baseline, at the end of the 19-day post-treatment, 30-day follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Temporal Interference Stimulation in people with Parkinson's Disease and Movement Disorders, run by YangPan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Pan (+8613952098253, panyang.zn@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of electromyographic tremor index (time frame: Baseline, at the end of the 19-day post-treatment, 30-day follow up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.