An interventional study of TIS-STN and TIS-GP in PARKINSON DIS, sponsored by Zhongnan Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: TIS-STN
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.
Device: TIS-GP
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 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.
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.
Time frame: 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.
Time frame: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
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.
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
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.
Time frame: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
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