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Directional PSA Versus STN DBS for TD-PD

7. juli 2026 opdateret af: LI DIANYOU, Ruijin Hospital

Directional Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This single-center trial utilizes directional deep brain stimulation (DBS) current-steering technology to compare the clinical efficacy and tolerability of the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (TD-PD) within the same subject. The study is optimized into a two-phase framework to maximize patient safety and protocol compliance:

Phase 1: Two-month post-implantation, acute mapping is conducted to define the therapeutic window for PSA and STN configurations in a blinded randomized order. If a configuration induces immediate, unmanageable adverse events before reaching efficacy, it is classified as "intolerant" and excluded from that participant's subsequent chronic phase.

Phase 2 (Chronic Crossover): Participants with tolerated configurations are entered into a chronic randomized phase with a blinded sequence of 2-month PSA or STN chronic stimulation. Following the core two-arm crossover, all eligible patients transition into an open-label, exploratory sequential add-on phase of 2-month with combined PSA+STN stimulation to evaluate potential synergistic benefits.

All participants will then be followed-up up to 12 months after surgery.

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

Studiesteder

  • Kina
      • Shanghai, Kina, 200025
        • Rekruttering
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • diagnosis of idiopathic Parkinson's disease
  • tremor-dominant subtype in the off-medication condition
  • modified Hoehn-Yahr scale of 2 to 4 in the off-medication condition
  • receiving regular anti-parkinsonian drugs for more than 6 weeks
  • good compliance and written informed consent provided

Exclusion Criteria:

  • Atypical parkinsonism
  • History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
  • Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
  • Presence of anatomical abnormalities in the target region
  • Clinically significant medical history that would increase pre-/post-operative complications
  • Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

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: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: directional PSA-STN
Participants randomized in this arm will receive the bilateral directional PSA stimulation and then will be crossovered to the bilateral directional STN stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional PSA stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional STN stimulation for another two months.
Enhed: directional Deep brain stimulation
active directional DBS with optimal stimulating parameters
Eksperimentel: directional STN-PSA
Participants randomized in this arm will receive the bilateral directional STN stimulation and then will be crossovered to the bilateral directional PSA stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional STN stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional PSA stimulation for another two months.
Enhed: directional Deep brain stimulation
active directional DBS with optimal stimulating parameters

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
The tremor subscore is derived from the sum of items 3.15 to 3.18 of the MDS-UPDRS-III. This measure directly compares the within-subject efficacy of directional PSA stimulation versus directional STN stimulation in the chronic cross-over phase. Lower scores indicate greater tremor suppression.
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)

Sekundære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III total score Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Berg Balance Scale score Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in 39-item Parkinsons disease questionnaire Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6)
Proportion of Participants with Acute Phase Intolerance to Single-Target Stimulation
Tidsramme: Up to 2 months after sugery
Up to 2 months after sugery
Adverse events
Tidsramme: Up to 12 months after surgery
Up to 12 months after surgery

Andre resultatmål

Resultatmål
Tidsramme
Change from Baseline in Beck Depression Inventory-II Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Beck Anxiety Inventory Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in nonmotor symptoms scale for Parkinson's disease (NMSS) Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Mini-Mental State Examination Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in levodopa equivalent daily dose Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in total electrical energy delivered Between PSA and STN Stimulation in the chronic randomized phase
Tidsramme: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)

Samarbejdspartnere og efterforskere

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

Sponsor

Ruijin Hospital

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)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • dPSA-STNforTD-PD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Parkinsons sygdom (PD)

Kliniske forsøg med directional Deep brain stimulation

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