NCT07745673|Recruiting
Comparative Study of TIS Efficacy Across Different Targets
tTIS
Comparative Efficacy of Temporal Interference Stimulation at Different Targets in Parkinson's Disease
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tTIS
Comparative Efficacy of Temporal Interference Stimulation at Different Targets in Parkinson's Disease
Sponsor study identifier
interventional
18
1 country
1
Study Start
June 29, 2026
Actual (reported)Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 29, 2026
Actual (reported)June 29, 2026
Actual (reported)August 4, 2026
Actual (reported)January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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
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
Baseline before the first stimulation session and immediately after completion of the 7-day intervention.
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.
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.
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.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
First Submitted
June 29, 2026
First Posted
August 4, 2026
Study Start
June 29, 2026
Actual (reported)Primary Completion
January 31, 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 4, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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