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

A legfontosabb adatok

Ki végzi
Ke Dong, MD
Hol
Guangzhou (Kína)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
40 fő, tervezett
Kezdés
2026. júl. 20.
Várható befejezés
2026. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Temporal Interference Stimulation
A regiszteradat frissítve
2026. augusztus 11.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan idiopátiás Parkinson-kórban szenvedő embereket keres, akik önállóan tudnak járni. Kétféle frekvenciájú agyi stimulációt (Temporal Interference Stimulation) vizsgál.

Nem
Nők és férfiak is részt vehetnek.
A betegség stádiuma
Idiopátiás Parkinson-kór, Hoehn és Yahr szerinti 1,5-3,0 stádium.
Korábbi kezelés
A beválasztás előtt legalább 4 hete stabil, levodopa-alapú Parkinson-kór elleni gyógyszeres kezelés, és a vizsgálat alatt nem tervezett gyógyszerváltás.

A részvétel fő kizáró okai

  • Nem végezhető el az MRI vagy az agyi stimuláció (például klausztrofóbia, vagy fémimplantátum a fejben vagy a bőr alatt)
  • A Parkinson-kór mellett más idegrendszeri betegség
  • Súlyos pszichiátriai betegség, vagy súlyos depresszió vagy szorongás
  • Korábbi mélyagyi stimulációs műtét
  • Más súlyos testi betegség, amely növelheti a kockázatot vagy akadályozhatja a részvételt

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

Helyszínek itt: Kína

  • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, KínaContact: Liu HanjunRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

Will different frequency 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. This design remains a parallel design, with two independent groups of subjects receiving different active interventions simultaneously rather than a sham control. 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, with the basal thalamic nuclei on the side opposite to the side where the patient's symptoms are most severe receiving stimulation at 130 Hz, and those on the other side receiving stimulation at 60 Hz. Subjects in the control arm will receive continuous, standardized TIS intervention targeting bilateral subthalamic nuclei with bilateral 130 Hz stimulation. The control intervention adopts identical operation procedures, equipment wearing mode and on-site operating environment as the formal TIS intervention, with the only difference being the stimulation frequency setting (bilateral 130 Hz in the control arm versus asymmetric frequency in the experimental arm). Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of different frequency TIS modes on motor dysfunction and speech impairment in Parkinson-related patients, and will also help to clarify the potential advantages of asymmetric frequency TIS over bilateral same-frequency TIS.

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

Receive continuous targeted intervention of either formal asymmetric frequency TIS (130 Hz on the contralateral side of severe symptoms, 60 Hz on the ipsilateral side) or bilateral 130 Hz TIS control intervention 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.

A vizsgálat 2 csoportja

  • Active Stimulation GroupA vizsgált kezelés

    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.

    Kezelés: Temporal Interference Stimulation

  • Active Control GroupMár használt kezelés, összehasonlításként

    Participants diagnosed with Parkinson's disease in the active control 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.

    Kezelés: Temporal Interference Stimulation

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Single-Center, Double-Blind Randomized Controlled Trial of Different Frequency Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
A regiszteradat frissítve
2026. augusztus 11.