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NCT Number: NCT07568067

Accelerated Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease and Secondary Parkinson's Syndrome

This clinical trial will evaluate the efficacy of accelerated Temporal Interference Stimulation (TIS) as a therapeutic intervention for individuals diagnosed with Parkinson's disease or secondary Parkinson's syndrome. Accelerated TIS will be delivered targeting the bilateral subthalamic nuclei of the brain. The primary objective is to assess whether accelerated TIS yields measurable improvements in motor performance and verbal speech function among enrolled subjects. Functional magnetic resonance imaging (fMRI) will be adopted as an auxiliary imaging modality to objectively characterize underlying cerebral functional alterations induced by accelerated TIS intervention. The core scientific research questions to be addressed in this trial are listed as follows:

* Will accelerated TIS administered to the bilateral subthalamic nuclei produce significant improvements in motor function and speech performance among enrolled subjects with Parkinson-related disorders? * What quantitative and qualitative modifications in cerebral functional activity will be detected via fMRI after standardized accelerated TIS intervention administration?

Investigators will implement a four-arm parallel controlled comparative design for all enrolled eligible subjects. All confirmed Parkinson's disease patients will undergo standardized random grouping and be allocated into two independent research arms. Subjects in the experimental arm will receive continuous, standardized accelerated TIS intervention targeting bilateral subthalamic nuclei. Subjects in the control arm will receive matched sham stimulation intervention. Sham stimulation adopts identical operation procedures, equipment wearing mode and on-site operating environment as formal accelerated TIS, with no valid neuromodulation therapeutic effect generated. Identical random grouping, intervention arrangement and controlled research design will be fully implemented in eligible subjects diagnosed with secondary Parkinson's syndrome. Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of accelerated TIS on motor dysfunction and speech impairment in Parkinson-related patients.

All enrolled subjects will complete the following standardized trial procedures in full compliance with the trial protocol:

* Receive continuous targeted intervention of either formal accelerated TIS or matched sham stimulation on bilateral subthalamic nuclei, with consecutive 5-day fixed-course administration in strict accordance with trial operating specifications * Complete unified fMRI brain scanning examinations and standardized motor function as well as speech function quantitative evaluation assessments at two fixed time nodes, including the baseline time point before intervention initiation and the follow-up time point after all intervention courses are completed * Truthfully record all adverse reactions and abnormal physical discomfort symptoms that occur throughout the whole intervention and follow-up observation cycle in standardized adverse event registration forms

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease, Secondary Parkinsonian Disorders Synucleinopathies

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Hanjun Liu

CONTACT

[email protected]

+86 15920175118

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of idiopathic Parkinson's disease or secondary parkinson's syndrome ; Hoehn-Yahr stage 1.5-3.
  • Ability to walk independently.
  • Ability to follow instructions, with no cognitive impairment.
  • Patient and their family agree to cooperate with treatment and provide written informed consent.

Exclusion criteria

  • Claustrophobia or presence of metallic implants precluding MRI examination and evaluation.
  • Severe dysfunction of vital organs including heart, lung, liver, kidney, etc.
  • Complicated with other neurological diseases such as cerebral infarction.
  • Presence of mental illness, severe depression, anxiety, etc., which may affect the accuracy of study results.
  • History of deep brain stimulation (DBS) surgery.
  • Patients unable or unwilling to cooperate with scale assessments.
  • Aged over 80 years old.

Treatment and study plan

temporal interference stimulation

Device

Sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation, administered twice daily (40 minutes per session, ≥1 hour rest interval between sessions). Stimulation targets are bilateral STN, with individualized electrode placement and current intensity determined via personalized modeling from patient MRI data. Active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field.

Other names: TIS, TI Stimulation, TI, cTIS, Transcranial Temporal Interference Stimulation

Primary outcomes

  1. The score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III)

    Time frame: From enrollment to 1 month after treatment

    The MDS-UPDRS-III is a standardized assessment tool to evaluate motor function symptoms in people with Parkinson's disease.It has a scoring range of 0 to 132 points, with higher scores meaning more severe motor disorders.

Secondary outcomes

  1. The scores of Mini-BESTest

    Time frame: From enrollment to 1 month after treatment

    The Mini-BESTest is a clinical assessment tool for evaluating balance function. It assesses the balance control system across multiple domains, with a scoring range of 0 to 28 points; higher scores indicate better balance function.

  2. 10-Meter Walk Test

    Time frame: From the enrollment to 1 month after treatment

    The 10-Meter Walk Test assesses gait speed and functional mobility by measuring the time required to walk 10 meters. Increased time reflects slower walking and worse mobility.

  3. Voice intensity

    Time frame: From the enrollment to 1 month after treatment

    Voice intensity is measured using Praat software. Voice intensity, expressed in dB SPL, reflects the loudness of the voice.

    This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in voice intensity may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention.

  4. Velocity of center of pressure (COP) sway

    Time frame: From the enrollment to 1 month after treatment

    Center of pressure (COP) sway velocity of subjects on stable and unstable surfaces is measured via a balance board, recording COP movement speed during standing.

    This indicator objectively assesses balance control and adaptability to different surfaces; abnormal increases indicate impaired balance, aiding evaluation of balance disorder severity and intervention effectiveness.

  5. BOLD-fMRI

    Time frame: From the enrollment to 1 month after treatment

    Functional MRI is used to acquire BOLD data. BOLD signals reflect regional brain activity and functional connectivity. This measure evaluates brain function and structural connectivity associated with motor and cognitive performance.

  6. Phonation duration

    Time frame: From the enrollment to 1 month after treatment

    Phonation duration refers to the continuous time of voluntary phonation. This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in phonation duration may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention.

  7. Fundamental frequency (F₀)

    Time frame: From the enrollment to 1 month after treatment

    Fundamental frequency (F₀) range of subjects' phonation is measured using Praat software. Fundamental frequency range is the interval between the minimum and maximum F₀ (unit: Hz) during phonation, reflecting the variability of voice pitch.

    This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in F₀ range may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention.

  8. Range of center of pressure (COP) sway

    Time frame: From the enrollment to 1 month after treatment

    Center of pressure (COP) sway range of subjects on stable and unstable surfaces is measured via a balance board, recording COP movement maximum horizontal displacement during standing.

    This indicator objectively assesses balance control and adaptability to different surfaces; abnormal increases indicate impaired balance, aiding evaluation of balance disorder severity and intervention effectiveness.

  9. Diffusion Tensor Imaging（DTI）

    Time frame: From the enrollment to 1 month after treatment

    Functional MRI is used to acquire Diffusion Tensor Imaging（DTI) data. DTI characterizes white matter microstructural integrity and fiber tract organization. This measure evaluates brain function and structural connectivity associated with motor and cognitive performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Hanjun

CONTACT

[email protected]

+86 15920175118

Zi Dan

CONTACT

[email protected]

+86 18922465578

Sponsors and collaborators

Lead sponsor

Ke Dong, MD

Other

Collaborators

  • Sun Yat-sen University

Registry information

Official study title

A Single-Center, Double-Blind Randomized Controlled Trial of Accelerated Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease Or Secondary Parkinson's Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
Jul 21, 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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