Parkinson DiseaseNCT06980935
STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications
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 evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are: 1. 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- MDS diagnosis of primary Parkinson's disease
- Hoehn \& Yahr stage < 3
- Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during the study
Who cannot join
- Presence of neurological disorders that may affect the study (e.g., Traumatic brain injury)
- History of antipsychotics, antidepressants, or dopamine modulators other than 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.
About this study
Official title: Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease
The goal of this clinical trial is to evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:
- Does the therapeutic effect of STN - tTIS relate to medication?
- The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.
Read more
Researchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.
- Visit the clinic once every 1 weeks for therapy and test.
- Record their symptoms and scores.
Read the detailed description
This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are assessed before and after each treatment.
- Conditions
- Parkinson Disease
- Being tested
- NervioX-2400
- Keywords
- subthalamic nucleus, transcranial temporal interference stimulation, MDS-UPDRS-Ⅲ
- 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 tTIS, each participant completed a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data were used to determine the tTIS montage and stimulation settings via computational modeling.
| Study group | Role | What they receive |
|---|---|---|
| Only use STN - tTIS therapy. | Experimental | Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "off" (≥12 hours withdrawal) and were evaluated for the MDS - UPDRS - III before and after treatment. Receives: Device: NervioX-2400 |
| STN - tTIS therapy is used in combination with medication. | Experimental | Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and were evaluated for the MDS - UPDRS - III 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. Minimum Value: 0, indicating no motor impairment. Maximum Value: 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 posted20 May 2025
- Study start14 Apr 2025
- Primary completion31 Aug 2025
- Study completion10 Sep 2025
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980935
- Sponsor's protocol ID
- 2025140A
- Status last verified
- Apr 2025
- First submitted
- 11 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease
- ClinicalTrials.gov ID
- NCT06980935
- Acronym / sponsor ID
- 2025140A
- Conditions
- Parkinson Disease
- Keywords
- subthalamic nucleus, transcranial temporal interference stimulation, MDS-UPDRS-Ⅲ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 20 May 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 evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:
- Does the therapeutic effect of STN - tTIS relate to medication?
- The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.
Researchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.
- Visit the clinic once every 1 weeks for therapy and test.
- Record their symptoms and scores.
Detailed description
This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are assessed before and after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only use STN - tTIS therapy. | Experimental | Device: NervioX-2400Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "off" (≥12 hours withdrawal) and were evaluated for the MDS - UPDRS - III before and after treatment. |
| STN - tTIS therapy is used in combination with medication. | Experimental | Device: NervioX-2400Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and were evaluated for the MDS - UPDRS - III 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)
- MDS diagnosis of primary Parkinson's disease
- Hoehn \& Yahr stage < 3
- Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during the study
Key exclusion criteria (4 listed)
- Presence of neurological disorders that may affect the study (e.g., Traumatic brain injury)
- History of antipsychotics, antidepressants, or dopamine modulators other than 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 tTIS, each participant completed a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data were used to determine the tTIS montage and stimulation settings via computational modeling. | Device | Only use STN - tTIS therapy., STN - tTIS therapy is used in combination with medication. |
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. Minimum Value: 0, indicating no motor impairment. Maximum Value: 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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. This study is not recruiting at the moment.
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: finished, as of the sponsor's last update on 9 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 9 Sep 2026.