Temporal Interference Stimulation (TIS)NCT07312279
Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease
A study testing TIS in people with Temporal Interference Stimulation (TIS) and Parkinson's Disease, run by Zhongnan Hospital.
Trial summary
The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Temporal Interference Stimulation (TIS), Parkinson's Disease
- What is being tested?
- TIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females aged 40 years or above;
- Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
- Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H\&Y) stage 1.5-2.5;
- Ability to walk independently without assistive devices for at least 5 minutes;
- Absence of severe freezing of gait (FOG);
- Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;
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- Stable medication dosage for at least 4 weeks prior to the study;
- Hoehn and Yahr (H\&Y) stage 1.5-2.5;
- Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.
Who cannot join
- Presence of other neurological disorders that may interfere with the study
- Mild or greater cognitive impairment (MoCA score ≤23)
- Orthopedic or other health conditions that may affect gait or balance
- Contraindications to MRI scanning, such as claustrophobia
- History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
- Other significant psychiatric history
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- Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)
- History of electroconvulsive therapy
- Concurrent participation in other gait- or balance-related intervention training
- Physician-diagnosed cardiovascular risk factors for exercise.
About this study
The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
- Being tested
- TIS
- Keywords
- TIS, Parkinson, UPDRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TISDevice
Temporal Interference Stimulation
| Study group | Role | What they receive |
|---|---|---|
| A:STN | Experimental | The subthalamic nucleus (STN) stimulation target Receives: Device: TIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS-3
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.
Measured: From enrollment through the 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion31 May 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 Temporal Interference Stimulation (TIS)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BinMei, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312279
- Sponsor's protocol ID
- 2025267
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07312279
- Acronym / sponsor ID
- 2025267
- Keywords
- TIS, Parkinson, UPDRS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Dec 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 primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A:STN | Experimental | Device: TISThe subthalamic nucleus (STN) stimulation target |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult males or females aged 40 years or above;
- Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
- Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H\&Y) stage 1.5-2.5;
- Ability to walk independently without assistive devices for at least 5 minutes;
- Absence of severe freezing of gait (FOG);
Key exclusion criteria (10 listed)
- Presence of other neurological disorders that may interfere with the study
- Mild or greater cognitive impairment (MoCA score ≤23)
- Orthopedic or other health conditions that may affect gait or balance
- Contraindications to MRI scanning, such as claustrophobia
- History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
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 |
|---|---|---|
| TISTemporal Interference Stimulation | Device | A:STN |
Primary outcome
UPDRS-3
Time frame: From enrollment through the 3-month follow-up
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.
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 31 Dec 2025.
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Comparative Study of TIS Efficacy Across Different Targets
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TIS in people with Temporal Interference Stimulation (TIS) and Parkinson's Disease, run by Zhongnan Hospital.
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 9 inclusion and 10 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
UPDRS-3 (time frame: From enrollment through the 3-month follow-up). 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 31 Dec 2025.