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Directional PSA Versus STN DBS for TD-PD

2026년 7월 7일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
      • Shanghai, 중국, 200025
        • 모병
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: directional Deep brain stimulation
active directional DBS with optimal stimulating parameters
실험적: 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.
장치: directional Deep brain stimulation
active directional DBS with optimal stimulating parameters

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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)

2차 결과 측정

결과 측정
기간
Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 2 months after sugery
Up to 2 months after sugery
Adverse events
기간: Up to 12 months after surgery
Up to 12 months after surgery

기타 결과 측정

결과 측정
기간
Change from Baseline in Beck Depression Inventory-II Between PSA and STN Stimulation in the chronic randomized phase
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ruijin Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2029년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 7일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • dPSA-STNforTD-PD

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

파킨슨병(PD)에 대한 임상 시험

directional Deep brain stimulation에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Latvia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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