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Идёт набор NCT07172295

Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.

Без фазы С лечением Parkinson Disease (PD) Essential Tremor Dystonic Tremor Continuous Theta Burst Stimulation Transcranial Focused Ultrasound

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Accelerated NaviFUS-ctbFUS stimulation.
Кому может быть актуально
Состояния в реестре: Parkinson Disease (PD), Essential Tremor, Dystonic Tremor, Continuous Theta Burst Stimulation Transcranial Focused Ultrasound. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.

Вмешательства

  • Процедура Accelerated NaviFUS-ctbFUS stimulation
    Three consecutive sessions of NaviFUS-ctbTUS stimulation were performed, with a 5-minute interval between each session. The acoustic pressure was set such that the estimated intracranial pressure at 30% skull transmission was approximately 0.5 MPa. The stimulation target was the center of the Vop, with a total of 7 stimulation points.

Первичные конечные точки

  • Incidence of Adverse Events Compared to Baseline [Safety Assessment] [Срок оценки: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.]
Вторичные конечные точки (1)
  • Change in Tremor Amplitude [Efficacy] [Срок оценки: On the day of first stimulation and the day of second stimulation: immediately before treatment, and at 0, 20, 40, and 60 minutes post-treatment; on the day of second stimulation, also after task-based fMRI.]

Критерии участия

Критерии включения

  • Age between 18 and 80 years.
  • Subjects must belong to one of the following three categories:
  • Patients with Parkinson's disease tremor who have an inadequate response to medication.
  • Patients with essential tremor who have an inadequate response to medication.
  • Patients with dystonic tremor who have an inadequate response to medication.
  • Subjects are willing to shave hair over the treatment area for focused ultrasound.
  • Stable medication regimen (types and dosages) for at least 4 weeks prior to study enrollment.
  • Normal liver and renal function (Creatinine < 1.3 mg/dL, GPT < 41 U/L).
  • Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use appropriate contraception from the first study treatment until at least 6 months after the last treatment to prevent pregnancy.

Критерии исключения

  • Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain stimulation (DBS) devices, pacemakers, or implantable cardioverter- defibrillators (ICDs).
  • Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open wounds, calp atrophy, or significant calcification confirmed by imaging along the ultrasound transmission pathway.
  • Pregnant or breastfeeding women.
  • Use of investigational drugs from other clinical trials.
  • Patients with major depressive disorder (Beck Depression Inventory-II score > 30 within the past year) or with suicidal ideation.
  • Any condition that, in the opinion of the investigator, may interfere with treatment efficacy or increase risk to the subject.
  • Presence of any brain tumors, vascular malformations, or significant traumatic brain injury.
  • Presence of significant psychiatric symptoms (Clinical Dementia Rating \[CDR\]
  • 2).
  • Use of anticoagulant medications.
  • Use of medications known to exacerbate tremor.
  • Tremor due to metabolic or psychogenic causes.
  • Coagulopathy or abnormal coagulation profiles, including any of the following:
  • Platelet count ≤ 100,000/µL
  • INR ≥ 1.5
  • PT ≥ 1.5 × upper limit of normal (ULN)
  • aPTT ≥ 1.5 × ULN
  • Fibrinogen ≤ 150 mg/dL
  • Inability to provide informed consent or comply with study procedures, posing potential safety concerns.
  • Insufficient skull density as determined by pre-treatment evaluation, resulting in ultrasound transmission efficiency less than 20%.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital Hsin-Chu Branch — Hsinchu

Идентификаторы

NCT: NCT07172295 · 202405134DINC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗