Parkinson DiseaseNCT07018388
Intrapatient Comparison of STN and GPi tTIS in PD
A study testing NervioX-2400 in people with Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NervioX-2400
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2025to 1 Nov 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary Parkinson's disease (MDS);
- Hoehn \& Yahr stage ≤ 3;
- Antiparkinsonian drugs must have remained unchanged in the past four weeks, and the dosage must have remained stable throughout the study.
Who cannot join
- Presence of neurological disorders that may affect the study (e.g., traumatic brain injury);
- Antipsychotics, antidepressants, or dopamine modulators outside of PD drugs;
- Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers);
- Unstable vital signs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intrapatient Comparison of Subthalamic and Globus Pallidus Internus Temporal Interference Stimulation in Parkinson's Disease
The goal of this clinical trial is to investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "off" medication states.
The main questions this study aims to answer are:
- Can tTIS significantly improve the motor symptoms of patients with Parkinson's disease?
- Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?
Read the detailed description
This clinical trial aims to verify the efficacy of tTIS in patients with Parkinson's disease and to explore which targets are better for improving PD motor symptoms.Patients were randomly assigned to receive Stimulation Type A, B, or C. Type A received STN-tTIS therapy; Type B received GPi-tTIS therapy; Type C received sham stimulation targeting the subthalamic nucleus.
Each session lasted 20 minutes, and patients were in the off-medication state for all treatments.The order of stimulation types was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.
- Conditions
- Parkinson Disease
- Being tested
- NervioX-2400
- Keywords
- subthalamic nucleus, Globus Pallidus Internus, transcranial temporal interference stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NervioX-2400Device
To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling.
NervioX-2400Device
To design the individualized GPi-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data is used to determine the GPi-tTIS montage and stimulation settings via computational modeling.
NervioX-2400Device
To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling.
| Study group | Role | What they receive |
|---|---|---|
| STN-tTIS | Experimental | Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment. Receives: Device: NervioX-2400 |
| GPi-tTIS | Experimental | Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment. Receives: Device: NervioX-2400 |
| Sham stimulation | Experimental | Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment. Receives: Device: NervioX-2400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS-Ⅲ scores
The score range for MDS-UPDRS-III is from 0 to 132. The minimum value is 0, indicating no motor impairment, and the maximum value is 132, indicating the most severe motor impairment. Higher scores on the MDS-UPDRS-III indicate worse outcomes, as they reflect greater severity of motor symptoms.
Measured: pre-intervention, immediately after the intervention
Secondary outcomes (1)
MDS-UPDRS-Ⅲ sub-scores
The MDS-UPDRS-III assesses motor symptoms in Parkinson's disease through sub-scores: Tremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors. Rigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement. Axial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments.
Measured: pre-intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start23 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018388
- Sponsor's protocol ID
- 2025140B
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapatient Comparison of Subthalamic and Globus Pallidus Internus Temporal Interference Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07018388
- Acronym / sponsor ID
- 2025140B
- Conditions
- Parkinson Disease
- Keywords
- subthalamic nucleus, Globus Pallidus Internus, transcranial temporal interference stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Jun 2025 (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 investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "off" medication states.
The main questions this study aims to answer are:
- Can tTIS significantly improve the motor symptoms of patients with Parkinson's disease?
- Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?
Detailed description
This clinical trial aims to verify the efficacy of tTIS in patients with Parkinson's disease and to explore which targets are better for improving PD motor symptoms.Patients were randomly assigned to receive Stimulation Type A, B, or C. Type A received STN-tTIS therapy; Type B received GPi-tTIS therapy; Type C received sham stimulation targeting the subthalamic nucleus.
Each session lasted 20 minutes, and patients were in the off-medication state for all treatments.The order of stimulation types was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STN-tTIS | Experimental | Device: NervioX-2400Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment. |
| GPi-tTIS | Experimental | Device: NervioX-2400Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment. |
| Sham stimulation | Experimental | Device: NervioX-2400Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary Parkinson's disease (MDS);
- Hoehn \& Yahr stage ≤ 3;
- Antiparkinsonian drugs must have remained unchanged in the past four weeks, and the dosage must have remained stable throughout the study.
Key exclusion criteria (4 listed)
- Presence of neurological disorders that may affect the study (e.g., traumatic brain injury);
- Antipsychotics, antidepressants, or dopamine modulators outside of PD drugs;
- Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers);
- Unstable vital signs.
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 |
|---|---|---|
| NervioX-2400To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling. | Device | GPi-tTIS |
| NervioX-2400To design the individualized GPi-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data is used to determine the GPi-tTIS montage and stimulation settings via computational modeling. | Device | STN-tTIS |
| NervioX-2400To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling. | Device | Sham stimulation |
Primary outcome
MDS-UPDRS-Ⅲ scores
Time frame: pre-intervention, immediately after the intervention
The score range for MDS-UPDRS-III is from 0 to 132. The minimum value is 0, indicating no motor impairment, and the maximum value is 132, indicating the most severe motor impairment. Higher scores on the MDS-UPDRS-III indicate worse outcomes, as they reflect greater severity of motor symptoms.
1 secondary outcome
MDS-UPDRS-Ⅲ sub-scores
Time frame: pre-intervention, immediately after the intervention
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NervioX-2400 in people with Parkinson Disease, run by Ruijin Hospital 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS-Ⅲ scores (time frame: pre-intervention, immediately after the intervention). 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 22 Apr 2026.