Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration
2026년 7월 10일 업데이트: Shengdi Chen, Ruijin Hospital
A Study on the Therapeutic Effects and Target Exploration of Temporal Interference-Based Noninvasive Deep Brain Stimulation in Patients With Idiopathic Parkinson's Disease and Parkinsonian Syndromes
This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation.
This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.
연구 개요
상태
초대로 등록
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Shanghai, 중국
- Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
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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:
- Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria.
- Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study.
- Hoehn and Yahr (H&Y) stage ≤ 3 in the "ON" medication state.
- Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.
- Able to maintain and cooperate with Parkinson's disease symptom diaries.
- Signed written informed consent.
Exclusion Criteria:
- Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes.
- Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies.
- Orthopedic or other medical conditions that could affect gait or balance.
- Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable.
- History of taking antipsychotic, antidepressant, or other medications that may affect dopamine levels.
- Contraindications to electrical stimulation, such as implanted cardiac pacemakers or a history of epilepsy.
- History of electroconvulsive therapy (ECT).
- Severe comorbidities, including cardiovascular disease, respiratory disease, or hepatic/renal dysfunction.
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GPi TIS
Participants with PD or PDS receive TIS targeting the contralateral globus pallidus internus (GPi).
Each group consists of 10 patients with PD and 10 patients with PDS.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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실험적: STN TIS
Participants with PD or PDS receive TIS targeting the contralateral subthalamic nucleus (STN).
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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실험적: Putamen TIS
Participants with PD or PDS receive TIS targeting the contralateral putamen.
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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실험적: LHA TIS
Participants with PD or PDS receive TIS targeting the contralateral lateral hypothalamic area (LHA).
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
|
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
|
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실험적: Dentate TIS
Participants with PD or PDS receive TIS targeting the ipsilateral cerebellar dentate nucleus.
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
|
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms.
Changes from baseline after real or sham stimulation will be analyzed and compared between groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary motor outcome
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The UMSARS is a rater-administered scale used to assess disease severity in patients with Parkinsonian syndromes, particularly multiple system atrophy.
The total score ranges from 0 to 104, with a higher score indicating greater disease severity.
The change in UMSARS score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Secondary motor outcome
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Freezing of Gait Questionnaire is used to assess the severity and frequency of freezing of gait in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 24, with a higher score indicating more severe freezing of gait.
The change in FOGQ score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Secondary motor outcome
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Berg Balance Scale is a rater-administered scale used to assess balance function and fall risk.
The total score ranges from 0 to 56, with a higher score indicating better balance function.
The change in Berg Balance Scale score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Hamilton Anxiety Rating Scale-14（HAMA-14）is a rater-administered scale used to assess the severity of anxiety symptoms.
The total score ranges from 0 to 56, with a higher score indicating more severe anxiety.
The change in HAMA-14 score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Hamilton Depression Rating Scale-17（HAMD-17）is a rater-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with a higher score indicating more severe depression.
The change in HAMD-17 score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Mini-Mental State Examination（MMSE）is a brief cognitive screening scale used to assess global cognitive function.
The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
The change in MMSE score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Montreal Cognitive Assessment（MoCA）is a brief cognitive screening scale used to assess global cognitive function, particularly mild cognitive impairment.
The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
The change in MoCA score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Non-Motor Symptoms Scale（NMSS）is a rater-administered scale used to assess the severity and frequency of non-motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 360, with a higher score indicating a greater non-motor symptom burden.
The change in NMSS score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Scales for Outcomes in Parkinson's Disease-Autonomic Dysfunction（SCOPA-AUT）is a patient-reported scale used to assess autonomic symptoms in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 69, with a higher score indicating more severe autonomic dysfunction.
The change in SCOPA-AUT score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Parkinson's Disease Questionnaire-39 Summary Index（PDQ-39 SI）is a patient-reported scale used to assess health-related quality of life in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 100, with a higher score indicating poorer quality of life.
The change in PDQ-39 SI score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part I is used to assess non-motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 52, with a higher score indicating more severe non-motor symptom burden.
The change in MDS-UPDRS Part I score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part II is used to assess motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 52, with a higher score indicating greater motor-related impairment in daily living.
The change in MDS-UPDRS Part II score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Changes in resting-state EEG β-band oscillation power before and after stimulation
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
기간: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Changes in whole-brain resting-state fMRI functional connectivity strength, with exploratory analyses focusing on the sensorimotor and basal ganglia networks, before and after stimulation
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: From baseline through study completion (up to 3 weeks)
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The number and severity of all AEs and SAEs will be collected and monitored throughout the study to evaluate the safety and tolerability of the intervention.
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From baseline through study completion (up to 3 weeks)
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스폰서
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 3일
기본 완료 (추정된)
2026년 9월 30일
연구 완료 (추정된)
2026년 9월 30일
연구 등록 날짜
최초 제출
2025년 12월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2025-622
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
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