Different Frequency Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease

NCT07721688 | Recruiting DMC

• 1 other identifier: Nos.82402971
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Different frequency TIS will be delivered targeting the bilateral subthalamic nuclei of the brain according to the patient's clinical symptoms. Specifically, the basal thalamic nuclei on the side opposite to the side where the patient's symptoms are most severe receive stimulation at 130 Hz, whilst those on the other side receive stimulation at 60 Hz. 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 cognitive function 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 two-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 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 TIS, with no valid neuromodulation therapeutic effect generated. Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of different frequency 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 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.

Conditions

Parkinson Disease (PD)

Outcome Measures

Primary Outcomes (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.

  From enrollment to 1 month after treatment

Secondary Outcomes (13)

• The scores of Mini-BESTest

  From enrollment to 1 month after treatment

• 10-Meter Walk Test

  From the enrollment to 1 month after treatment

• Voice intensity

  From the enrollment to 1 month after treatment

• Velocity of center of pressure (COP) sway

  From the enrollment to 1 month after treatment

• BOLD-fMRI

  From the enrollment to 1 month after treatment

Study Arms (2)

Active Stimulation Group

EXPERIMENTAL

Participants 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. For the stimulation protocol, a unified carrier frequency of 2000 Hz is adopted for bilateral STN intervention. Specifically, TI stimulation with an envelope frequency of 130 Hz is delivered to the STN contralateral to the patient's most symptomatic side, while TI stimulation with an envelope frequency of 60 Hz is administered to the STN ipsilateral to the patient's most symptomatic side.

Device: Temporal Interference Stimulation

Sham Stimulation Group

SHAM COMPARATOR

Participants 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.

Device: Temporal Interference Stimulation

Interventions

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. A fixed carrier frequency of 2000 Hz is used for all STN stimulation. Specifically, therapeutic temporal interference stimulation with an envelope frequency of 130 Hz is delivered to the STN contralateral to the patient's most symptomatic side, while stimulation with an envelope frequency of 60 Hz is applied to the STN ipsilateral to the most symptomatic side to produce targeted therapeutic interference fields.

Also known as: TIS, TI Stimulation, TI, tTIS, Transcranial Temporal Interference Stimulation

Active Stimulation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease diagnosed by neurologists according to the Movement Disorder Society Clinical Diagnostic Criteria;
• Hoehn and Yahr stage 1.5-3.0;
• Stable levodopa-based antiparkinsonian medication for at least 4 weeks before enrolment, with no planned medication change during the trial period;
• Ability to walk independently;
• Ability to understand and follow study instructions and complete the required assessments, with no severe cognitive impairment as screened by the Montreal Cognitive Assessment and/or Mini-Mental State Examination according to prespecified thresholds;
• Willingness to participate and provide written informed consent.

You may not qualify if:

• Any contraindication to MRI or tTIS, including claustrophobia or ferromagnetic intracranial or subcutaneous implants;
• Significant systemic disease that could increase study risk or interfere with trial participation;
• Neurological disorders other than Parkinson's disease;
• Major psychiatric disorder or severe depression or anxiety;
• History of deep brain stimulation surgery;
• Inability or unwillingness to complete all interventions and assessments.

Sponsors & Collaborators

• Ke Dong, MD: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Dan Zi

CONTACT

+8618922465578; 925343654@qq.com

Liu Hanjun

CONTACT

+86 15920175118; lhanjun@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

CN (1)