Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration

Официальное название

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

Обзор

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.

Вмешательства

• Устройство AB Temporal Interference Stimulation
  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.
• Устройство BA Temporal Interference Stimulation
  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;

Первичные конечные точки

• Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]

Вторичные конечные точки (12)

• Secondary motor outcome [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Secondary motor outcome [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Secondary motor outcome [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]
• Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes [Срок оценки: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT07698236 · 2025-622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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