Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

Effects and Mechanisms of Non-invasive Deep Brain Stimulation in Patients With Parkinson's Disease

The goal of this clinical trial is to learn whether a type of brain stimulation called transcranial temporal interference stimulation (TIS) of the internal globus pallidus (GPi) can help improve movement symptoms in people with Parkinson's disease. The study will also look at how TIS changes brain activity related to these improvements.

The main questions this study aims to answer are:

• How much can repeated TIS sessions improve movement symptoms in people with Parkinson's disease?
• Can these improvements last for up to two months after the treatment ends?
• What changes in brain activity happen along with the improvements?

Researchers will compare people who receive active TIS with those who receive sham (placebo-like) stimulation to see whether active TIS leads to better movement outcomes.

Participants will:

• Receive 10 sessions of active or sham TIS over two weeks
• Complete movement assessments during the two-week treatment and again 2, 4, and 8 weeks afterward
• Complete brain activity assessments before and after the two-week treatment

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Transcranial Temporal Interference Stimulation (TIS)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Liu, PhD; Phone Number: +86 21 65507351; Email: yuliu@sus.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200438
      • Recruiting
      • Shanghai University of Sport
      • Contact: Ethics Committee of the Shanghai University of Sport; Phone Number: +86 21 65508179; Email: lunli@sus.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A physician-diagnosed idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) diagnostic criteria, with onset after the age of 40.
• Stable antiparkinsonian medication regimen, including levodopa-containing therapy, unchanged for at least 4 weeks before and during the trial.
• Hoehn and Yahr (H&Y) stages 1.5 to 3 and ability to walk unassisted.
• Absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 21.

Exclusion Criteria:

• Any contraindication for MRI or transcranial temporal interference stimulation (TIS), including claustrophobia, metallic implants in the head or heart, or a history of electroconvulsive therapy.
• Current use of antipsychotic, antidepressant, or other dopamine-modulating medications.
• Presence of orthopedic conditions that may interfere with motor assessments, such as osteoarthritis or recent orthopedic surgery (within the past 6 months).
• History of physician-diagnosed major psychiatric illness.
• Physician-diagnosed cardiovascular risks that could contraindicate exercise or study participation.
• Prior history of deep brain stimulation (DBS) surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIS Group; Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.	Device: Transcranial Temporal Interference Stimulation (TIS); Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants receive 10 stimulation sessions over two weeks. The sham TIS condition uses the same setup but applies low-frequency currents without generating an interference pattern.
Sham Comparator: Sham Group; Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.	Device: Transcranial Temporal Interference Stimulation (TIS); Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants receive 10 stimulation sessions over two weeks. The sham TIS condition uses the same setup but applies low-frequency currents without generating an interference pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score	Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Diary Assessment of Motor States	The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good motor control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control.	Baseline, immediately after 1 and 2 weeks of intervention
Parkinson's Disease Questionnaire-39 (PDQ-39) Score	Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score	Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score	Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Epworth Sleepiness Scale Score	Change in daytime sleepiness assessed using the Epworth Sleepiness Scale . The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Parkinson's Disease Sleep Scale-2 Score	Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2. The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome).	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Gait Performance Measures	Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions. Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials. Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions.	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Balance Performance Measures	Changes in balance performance will be assessed using a force platform during standardized standing balance tasks. Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability. Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity.	Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Magnetic Resonance Imaging (MRI) Measures	Changes in brain structure and/or function will be assessed using magnetic resonance imaging (MRI). MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols.	Baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: Shanghai University of Sport

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Estimated): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Parkinson's disease; motor symptoms; TIS; transcranial temporal interference stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 102772024RT146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No