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Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease (STN-tTIS-PD)

2. juni 2026 opdateret af: Xiaoying Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD). The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention. The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days. Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side. Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region. The sham group follows the same procedure but does not receive effective stimulation. The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200080
        • Rekruttering
        • Shanghai General Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Beskrivelse

Inclusion Criteria:

  • Aged 50-85 years, male or female.
  • Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
  • Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
  • Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
  • Written informed consent signed by the study participant.

Exclusion Criteria:

  • Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
  • Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
  • Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
  • Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
  • Presence of contraindications to MRI or inability to tolerate MRI examination.
  • Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
  • New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
  • History of epilepsy.
  • Pregnancy or breastfeeding.
  • Any other condition judged by the investigator as unsuitable for participation in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: the experimental group
real stimulation
Enhed: real transcranial temporal interference stimulation
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
Sham-komparator: the control group
sham stimulation
Enhed: sham transcranial temporal interference stimulation
The sham stimulation is administered using the same procedure as the real tTIS.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of motor function in PD
Tidsramme: Changes from baseline after 5 days of intervention (Day 5)
the scores of UPDRS III [OFF])
Changes from baseline after 5 days of intervention (Day 5)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of motor function in PD
Tidsramme: Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
the scores of UPDRS III [OFF] and [ON]
Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
Changes of Motor Complications in PD
Tidsramme: Day 5, Day 15, Day 35
the scores of UPDRS IV
Day 5, Day 15, Day 35
Assessment of changes in cognition
Tidsramme: Day 5, Day 15, Day 35
the scores of MoCA
Day 5, Day 15, Day 35
Assessment of changes in anxiety
Tidsramme: Day 5, Day 15, Day 35
the scores of HAMA
Day 5, Day 15, Day 35
Assessment of changes in depression
Tidsramme: Day 5, Day 15, Day 35
the scores of HAMD
Day 5, Day 15, Day 35
Assessment of changes in sleep
Tidsramme: Day 5, Day 15, Day 35
the scores of PSQI
Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
Tidsramme: Day 5, Day 15, Day 35
the scores of ESS
Day 5, Day 15, Day 35
Assessment of changes in RBD
Tidsramme: Day 5, Day 15, Day 35
the scores of RBDSQ
Day 5, Day 15, Day 35
Assessment of changes in RLS
Tidsramme: Day 5, Day 15, Day 35
the scores of IRLSRS
Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
Tidsramme: Day 5, Day 15, Day 35
the scores of UPDRS I
Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
Tidsramme: Time Frame: Day 5, Day 15, Day 35
the scores of UPDRS II
Time Frame: Day 5, Day 15, Day 35

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changs of brain connectivity in the PD brain
Tidsramme: After 5 days of intervention relative to baseline
functional magnetic resonance imaging (fMRI)
After 5 days of intervention relative to baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Shanghai1st-2026-tTIS
  • No. 02.06.02.26.19 (Andet bevillings-/finansieringsnummer: Basic and Clinical Collaborative Research Program of Shanghai General Hospital)

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Kliniske forsøg med Parkinsons sygdom (PD)

Kliniske forsøg med real transcranial temporal interference stimulation

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