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Parkinson DiseaseNCT07568067

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

A study testing Temporal Interference Stimulation in people with Parkinson Disease and Parkinson Disease, Secondary, run by Ke Dong, MD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 85 years
What is being tested?
Temporal Interference Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
21 Apr 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Hanjun Liu, +86 15920175118, lhanjun@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official 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

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?
Read more

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
Being tested
Temporal Interference Stimulation
Medical subject headings
Parkinson Disease, Parkinson Disease, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporal Interference StimulationDevice

    Also called TIS, TI Stimulation, TI, cTIS

    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.

  • Temporal Interference StimulationDevice

    Also called TI, TIS, TI Stimulation, Transcranial Temporal Interference Electrical Stimulation

    Sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation (sham control), 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. Sham stimulation uses two identical high frequencies (2000 Hz and 2000 Hz) to eliminate the therapeutic interference effect, matching all other procedural details to the active stimulation arm.

Study groups in NCT07568067
Study groupRoleWhat they receive
Active Stimulation Group-Parkinson's diseaseExperimentalParticipants diagnosed with Parkinson's disease in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field.
Receives: Device: Temporal Interference Stimulation
Sham Stimulation Group-Parkinson's diseaseSham comparatorParticipants diagnosed with Parkinson's disease in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition.
Receives: Device: Temporal Interference Stimulation
Active Stimulation Group- secondary Parkinson's syndromeExperimentalParticipants diagnosed with secondary Parkinson's syndrome in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field.
Receives: Device: Temporal Interference Stimulation
Sham Stimulation Group- secondary Parkinson's syndromeSham comparatorParticipants diagnosed with secondary Parkinson's syndrome in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition.
Receives: Device: Temporal Interference Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: From enrollment to 1 month after treatment

Secondary outcomes (9)
  1. The scores of Mini-BESTest

    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.

    Measured: From enrollment to 1 month after treatment

  2. 10-Meter Walk Test

    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.

    Measured: From the enrollment to 1 month after treatment

  3. Voice intensity

    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.

    Measured: From the enrollment to 1 month after treatment

  4. Velocity of center of pressure (COP) sway

    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.

    Measured: From the enrollment to 1 month after treatment

  5. BOLD-fMRI

    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.

    Measured: From the enrollment to 1 month after treatment

  6. Phonation duration

    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.

    Measured: From the enrollment to 1 month after treatment

  7. Fundamental frequency (F₀)

    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.

    Measured: From the enrollment to 1 month after treatment

  8. Range of center of pressure (COP) sway

    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.

    Measured: From the enrollment to 1 month after treatment

  9. Diffusion Tensor Imaging(DTI)

    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.

    Measured: From the enrollment to 1 month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start21 Apr 2026
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07568067
Sponsor's protocol ID
Nos.82372556
Status last verified
Apr 2026
First submitted
19 Apr 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Temporal Interference Stimulation in people with Parkinson Disease and Parkinson Disease, Secondary, run by Ke Dong, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zi Dan (+86 18922465578, zidan@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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