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Completed

NCT Number: NCT07309198

Temporal Interference Stimulation on Motor Symptoms in 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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Temporal Interference Stimulation (TIS)

Device

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.

Primary outcomes

  1. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  2. Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.

Secondary outcomes

  1. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  2. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  3. Change From Baseline in the Epworth Sleepiness Scale Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  4. Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  5. Change From Baseline in the Gait Performance Measures

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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.

  6. Change From Baseline in the Balance Performance Measures

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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.

  7. Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures

    Time frame: Baseline and immediately after the intervention

    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.

  8. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.

  9. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.

  10. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.

  11. Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.

Other outcomes

  1. Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)

    Time frame: Baseline, weekly averages during weeks 1 and 2 of the intervention

    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 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.

  2. Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)

    Time frame: Baseline, weekly averages during weeks 1 and 2 of the intervention

    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 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 the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week.

    The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control.

  3. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    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).

  4. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.

  5. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.

  6. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.

  7. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.

  8. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.

  9. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.

  10. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.

  11. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score

    Time frame: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

    Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.

Sponsors and collaborators

Lead sponsor

Shanghai University of Sport

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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