The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD

Обзор

To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.

Подробное описание

Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Вмешательства

• Устройство Transcranial temporal interference stimulation (tTIS)
  The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.
• Устройство Sham transcranial temporal interference stimulation (tTIS)
  Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

Первичные конечные точки

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Срок оценки: On intervention Day 1, Day 10 and 1-month follow-up.]

Вторичные конечные точки (2)

• emotional symptoms assessed by the HAMA [Срок оценки: on intervention Day 1, Day 10 and 1-month follow-up]
• emotional symptoms assessed by the HAMD [Срок оценки: On intervention Day 1, Day 10 and 1-month follow-up.]

Критерии участия

Критерии включения

• Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
• Hoehn-Yahr stage 1.5-4;
• Age > 50 years old;
• No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;
• No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;
• No change in medication regimen in the four weeks prior to enrollment;
• Right-handed.

Критерии исключения

• History of other neuropsychiatric disorders;
• History of alcohol or drug abuse;
• Previous history of TMS or traditional TES treatment;
• Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT06931483 · AHMU-tTIS-PD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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