Comparative Study of TIS Efficacy Across Different Targets (NCT07745673) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Study of TIS Efficacy Across Different Targets
China18 participantsStarted 2026-06-29
Plain-language 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 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. Disease duration ≥2 years since diagnosis, clinically stable, and able to comply with study assessments and interventions;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something called TIS — transcranial interferential stimulation — on Parkinson's motor symptoms over 7 days. Can you explain how this type of brain stimulation works and whether there's enough safety data so far for someone at my stage of Parkinson's to consider it?
2The trial is listed as Phase NA, which suggests it may be more of an exploratory or feasibility study rather than a late-stage efficacy trial. What does that mean for how confident we can be in the results, and should I think about standard treatments first?
3The study is measuring changes in brain activity and connectivity after just 7 days of TIS. Does a 7-day window give us meaningful information about whether this could help my motor symptoms longer term, or is this mainly a research snapshot?
4Since this trial is actively recruiting right now, what would my participation actually look like day-to-day — would I need to come in every day for 7 days, and would that be realistic given my current condition and schedule?
5Are there any existing Parkinson's therapies — like medication adjustments or other forms of brain stimulation such as deep brain stimulation — that you'd recommend I explore before or alongside considering this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in motor symptoms in PD patients
Timeframe: Immediately before the first stimulation session on Day 1 and immediately after the final stimulation session on Day 7.
2
Changes From Baseline in Regional Spontaneous Brain Activity and Seed-Based Functional Connectivity After 7 Days of TIS
Timeframe: Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
. Stable medication regimen for at least 4 weeks prior to the study;
Exclusion criteria
. 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;
. History of epilepsy, traumatic brain injury, or implanted metallic devices in the brain or heart (e.g., stimulators, pacemakers) or other contraindications;