PARKINSON DIStTISNCT07745673
Comparative Study of TIS Efficacy Across Different Targets
A study testing TIS-STN and TIS-GP in people with PARKINSON DIS, run by Zhongnan Hospital at 1 site in China.
Trial summary
This prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- PARKINSON DIS
- What is being tested?
- TIS-STN and TIS-GP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2026to 31 Dec 2027
- 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;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria, with age of onset ≥40 years;
- Previous or current treatment with dopamine replacement therapy (e.g., levodopa) with good response;
- Hoehn and Yahr (H\&Y) stage 1.5-2.5;
- Able to walk independently for at least 5 minutes without assistive devices;
- No severe freezing of gait (FOG);
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- Disease duration ≥2 years since diagnosis, clinically stable, and able to comply with study assessments and interventions;
- Stable medication regimen for at least 4 weeks prior to the study;
- Signed informed consent form; subject or legal guardian is able to understand and willing to participate in this study.
Who cannot join
- Presence of other neurological disorders that may affect the study (e.g., ...);
- Mild cognitive impairment or above (MoCA ≤23);
- Orthopedic or other medical conditions that may affect gait or balance;
- Contraindications to MRI, such as claustrophobia;
- History of antipsychotic, antidepressant, or other medications that may affect dopamine levels;
- History of other severe psychiatric disorders;
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- History of epilepsy, traumatic brain injury, or implanted metallic devices in the brain or heart (e.g., stimulators, pacemakers) or other contraindications;
- History of electroconvulsive therapy (ECT);
- Currently participating in other gait- or balance-related intervention training;
- Physician-diagnosed cardiovascular risk factors for exercise.
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, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Bin Mei, 02767812787, znyyll@126.com
About this study
Official title: Comparative Efficacy of Temporal Interference Stimulation at Different Targets in Parkinson's Disease
This prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in patients with Parkinson's disease (PD).
Eighteen participants with idiopathic PD will be randomly assigned in a 1:1 ratio to the STN-TIS or GPi-TIS group. Participants will receive one 20-minute TIS session daily for 7 consecutive days. Motor symptoms will be assessed using the MDS-UPDRS Part III immediately before and after each daily stimulation session. Resting-state functional magnetic resonance imaging (fMRI) and 64-channel electroencephalography (EEG) will be performed before the first stimulation session and immediately after completion of the 7-day intervention.
Read more
The primary outcomes are: (1) change in MDS-UPDRS Part III score from Day 1 before stimulation to Day 7 after stimulation; and (2) changes in regional spontaneous brain activity and seed-based functional connectivity measured using resting-state fMRI. Secondary outcomes are: (1) daily immediate changes in MDS-UPDRS Part III scores and the proportion of participants achieving at least 30% improvement at Day 7; and (2) changes in resting-state 64-channel EEG relative bandpower.
Safety and tolerability will be evaluated by monitoring adverse events and local skin reactions throughout the intervention. This study aims to provide preliminary evidence regarding target-dependent functional response patterns associated with STN- and GPi-targeted TIS in PD.
- Conditions
- PARKINSON DIS
- Being tested
- TIS-STN, TIS-GP
- Keywords
- Temporal Interference Stimulation, Parkinson's disease, Non-invasive deep brain stimulation, Randomized controlled trial
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIS-STNDevice
TIS stimulation target is the subthalamic nucleus (STN) , with a current intensity of 2 mA, base frequency of 2000 Hz, frequency difference of 130 Hz, and stimulation duration of 20 minutes.
TIS-GPDevice
TIS stimulation target is the globus pallidus (GP), with a current intensity of 2 mA, base frequency of 2000 Hz, frequency difference of 130 Hz, and stimulation duration of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Stimulation target: subthalamic nucleus (frequency difference = 130 Hz), stimulation duration: 20 minutes, with 30-second ramp-up at the beginning and 30-second ramp-down at the end. All four stimulation impedances must be maintained at ≤10 KΩ. Duration: 7 consecutive days. Receives: Device: TIS-STN |
| Group B | Active comparator | Stimulation target: globus pallidus (frequency difference = 130 Hz), stimulation duration: 20 minutes, with 30-second ramp-up at the beginning and 30-second ramp-down at the end. All four stimulation impedances must be maintained at ≤10 KΩ. Duration: 7 consecutive days. Receives: Device: TIS-GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor symptoms in PD patients
Motor symptoms will be assessed using the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III). All assessments will be conducted after withdrawal of antiparkinsonian medications for at least 12 hours. The change score will be calculated as the MDS-UPDRS Part III score immediately after the final stimulation session on Day 7 minus the score immediately before the first stimulation session on Day 1. A negative change value indicates improvement in motor symptoms.
Measured: Immediately before the first stimulation session on Day 1 and immediately after the final stimulation session on Day 7.
Changes From Baseline in Regional Spontaneous Brain Activity and Seed-Based Functional Connectivity After 7 Days of TIS
Regional spontaneous brain activity and functional connectivity will be assessed using resting-state functional magnetic resonance imaging. Regional spontaneous brain activity will be evaluated primarily using the standardized amplitude of low-frequency fluctuation (zALFF). Seed-based functional connectivity will be calculated using predefined subthalamic nucleus and globus pallidus internus seed regions, and correlation coefficients will be transformed to Fisher z values. For each imaging measure, the change value will be calculated as the post-intervention value minus the baseline value. Within-group changes and between-group differences will be evaluated to characterize stimulation-related and target-dependent brain functional response patterns.
Measured: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
Secondary outcomes (2)
Immediate Changes in MDS-UPDRS Part III Scores and Clinical Response Rate During the 7-Day TIS Intervention
MDS-UPDRS Part III will be assessed immediately before and immediately after each daily stimulation session during the 7-day intervention. The immediate within-session change for each treatment day will be calculated as the post-stimulation score minus the corresponding pre-stimulation score, with negative values indicating improvement.
Clinical response will also be evaluated using the percentage change in MDS-UPDRS Part III score from immediately before the first stimulation session on Day 1 to immediately after the final stimulation session on Day 7. Percentage improvement will be calculated as the Day 1 pre-stimulation score minus the Day 7 post-stimulation score, divided by the Day 1 pre-stimulation score and multiplied by 100. Participants with an improvement of at least 30% will be classified as responders, and the response rate will be calculated as the proportion of responders in each stimulation group.
Measured: Immediately before and immediately after each stimulation session on Days 1 through 7; response rate assessed from immediately before the first stimulation session on Day 1 to immediately after the final stimulation session on Day 7.
Change From Baseline in Resting-State 64-Channel EEG Relative Bandpower After 7 Days of TIS
Resting-state 64-channel electroencephalography will be recorded under eyes-closed conditions. Relative bandpower will be calculated for predefined frequency bands, including the Parkinsonian tremor-frequency range, theta, alpha, low-beta, high-beta, and total-beta bands, across predefined scalp regions. For each region-by-frequency measure, the change value will be calculated as the post-intervention relative bandpower minus the baseline relative bandpower. Exploratory principal component analysis will be used to characterize multivariate EEG response patterns associated with STN-targeted and GPi-targeted TIS.
Measured: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start29 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT07745673
- Sponsor's protocol ID
- linyanlun2025267
- Acronym
- tTIS
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 4 Aug 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Temporal Interference Stimulation at Different Targets in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07745673
- Acronym / sponsor ID
- tTIS / linyanlun2025267
- Conditions
- PARKINSON DIS
- Keywords
- Temporal Interference Stimulation, Parkinson's disease, Non-invasive deep brain stimulation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Aug 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.
This prospective, randomized, participant- and outcome-assessor-blinded, parallel-group exploratory trial will compare the target-dependent clinical, neuroimaging, and electrophysiological effects of temporal interference stimulation (TIS) targeting the subthalamic nucleus (STN) or globus pallidus internus (GPi) in patients with Parkinson's disease (PD).
Eighteen participants with idiopathic PD will be randomly assigned in a 1:1 ratio to the STN-TIS or GPi-TIS group. Participants will receive one 20-minute TIS session daily for 7 consecutive days. Motor symptoms will be assessed using the MDS-UPDRS Part III immediately before and after each daily stimulation session. Resting-state functional magnetic resonance imaging (fMRI) and 64-channel electroencephalography (EEG) will be performed before the first stimulation session and immediately after completion of the 7-day intervention.
The primary outcomes are: (1) change in MDS-UPDRS Part III score from Day 1 before stimulation to Day 7 after stimulation; and (2) changes in regional spontaneous brain activity and seed-based functional connectivity measured using resting-state fMRI. Secondary outcomes are: (1) daily immediate changes in MDS-UPDRS Part III scores and the proportion of participants achieving at least 30% improvement at Day 7; and (2) changes in resting-state 64-channel EEG relative bandpower.
Safety and tolerability will be evaluated by monitoring adverse events and local skin reactions throughout the intervention. This study aims to provide preliminary evidence regarding target-dependent functional response patterns associated with STN- and GPi-targeted TIS in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: TIS-STNStimulation target: subthalamic nucleus (frequency difference = 130 Hz), stimulation duration: 20 minutes, with 30-second ramp-up at the beginning and 30-second ramp-down at the end. All four stimulation impedances must be maintained at ≤10 KΩ. Duration: 7 consecutive days. |
| Group B | Active comparator | Device: TIS-GPStimulation target: globus pallidus (frequency difference = 130 Hz), stimulation duration: 20 minutes, with 30-second ramp-up at the beginning and 30-second ramp-down at the end. All four stimulation impedances must be maintained at ≤10 KΩ. Duration: 7 consecutive days. |
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;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria, with age of onset ≥40 years;
- Previous or current treatment with dopamine replacement therapy (e.g., levodopa) with good response;
- Hoehn and Yahr (H\&Y) stage 1.5-2.5;
- Able to walk independently for at least 5 minutes without assistive devices;
Key exclusion criteria (10 listed)
- Presence of other neurological disorders that may affect the study (e.g., ...);
- Mild cognitive impairment or above (MoCA ≤23);
- Orthopedic or other medical conditions that may affect gait or balance;
- Contraindications to MRI, 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 |
|---|---|---|
| TIS-STNTIS stimulation target is the subthalamic nucleus (STN) , with a current intensity of 2 mA, base frequency of 2000 Hz, frequency difference of 130 Hz, and stimulation duration of 20 minutes. | Device | Group A |
| TIS-GPTIS stimulation target is the globus pallidus (GP), with a current intensity of 2 mA, base frequency of 2000 Hz, frequency difference of 130 Hz, and stimulation duration of 20 minutes. | Device | Group B |
Primary outcome
Changes in motor symptoms in PD patients
Time frame: Immediately before the first stimulation session on Day 1 and immediately after the final stimulation session on Day 7.
Motor symptoms will be assessed using the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III). All assessments will be conducted after withdrawal of antiparkinsonian medications for at least 12 hours. The change score will be calculated as the MDS-UPDRS Part III score immediately after the final stimulation session on Day 7 minus the score immediately before the first stimulation session on Day 1. A negative change value indicates improvement in motor symptoms.
Changes From Baseline in Regional Spontaneous Brain Activity and Seed-Based Functional Connectivity After 7 Days of TIS
Time frame: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
Regional spontaneous brain activity and functional connectivity will be assessed using resting-state functional magnetic resonance imaging. Regional spontaneous brain activity will be evaluated primarily using the standardized amplitude of low-frequency fluctuation (zALFF). Seed-based functional connectivity will be calculated using predefined subthalamic nucleus and globus pallidus internus seed regions, and correlation coefficients will be transformed to Fisher z values. For each imaging measure, the change value will be calculated as the post-intervention value minus the baseline value. Within-group changes and between-group differences will be evaluated to characterize stimulation-related and target-dependent brain functional response patterns.
2 secondary outcomes
Immediate Changes in MDS-UPDRS Part III Scores and Clinical Response Rate During the 7-Day TIS Intervention
Time frame: Immediately before and immediately after each stimulation session on Days 1 through 7; response rate assessed from immediately before the first stimulation session on Day 1 to immediately after the final stimulation session on Day 7.
Change From Baseline in Resting-State 64-Channel EEG Relative Bandpower After 7 Days of TIS
Time frame: Baseline before the first stimulation session and immediately after completion of the 7-day 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 4 Aug 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 TIS-STN and TIS-GP in people with PARKINSON DIS, run by Zhongnan 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 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: looking for participants now, as of the sponsor's last update on 4 Aug 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?
Contact Yang Pan (13952098253, 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 in motor symptoms in PD patients (time frame: Immediately before the first stimulation session on Day 1 and immediately after the final stimulation session on Day 7.). 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 4 Aug 2026.