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Идёт набор NCT07399496

Accelerated TMS for Apathy in PD

Без фазы С лечением Parkinson Disease

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 intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC).
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 45 лет — 85 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
США
Следующий шаг
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Официальное название

Accelerated Transcranial Magnetic Stimulation (TMS) for Apathy in Parkinson's Disease

Обзор

This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo six treatment visits over two weeks, receiving eight iTBS sessions per day. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at two and four weeks post-treatment.

Подробное описание

This study is designed to explore a new treatment option for people with Parkinson's disease who experience apathy, which means loss of motivation or interest in daily activities. Apathy is common in Parkinson's disease and can lower quality of life, but current treatments are limited. Investigators are testing whether a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) is tolerable, acceptable and can be used to improve apathy in patients with Parkinson's disease. TMS delivers brief magnetic pulses to specific areas of the brain that are linked to motivation and decision-making. In this study, Investigators will use an "accelerated" version of TMS, which gives several short sessions in a single day, reducing the number of visits required. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating apathy in people with Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.

Вмешательства

  • Устройство Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)
    Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) (MagVenture MagPro with cooled figure-of-eight coil; Brainsight neuronavigation; 120% rMT; 6 treatment days over \~2 weeks; 8 sessions/day; 600 pulses/session; 10-15 min inter-session interval).

Первичные конечные точки

  • TMS adherence [Срок оценки: Day 1 through Day 14 (6 treatment days over approximately 2 weeks)]
  • Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability) [Срок оценки: Measured during each treatment day (6 days within a 2-week period)]
  • Apathy severity as measured by the Lille Apathy Rating Scale [Срок оценки: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment]
  • Target engagement (dmPFC network modulation) [Срок оценки: Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)]
Вторичные конечные точки (3)
  • Goal attainment [Срок оценки: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment]
  • Change in apathy as measured by the Dimensional Apathy Scale [Срок оценки: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"]
  • Change in apathy-related behavior as measured by the Frontal Systems Behavior Scale [Срок оценки: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"]

Критерии участия

Критерии включения

  • Age 45-85
  • Diagnosis of Parkinson's Disease
  • AES ≥37
  • Stable PD medications
  • Caregiver informant available

Критерии исключения

  • MRI/TMS contraindications
  • Severe cognitive impairment (MoCA <21)
  • Psychiatric disorders (bipolar, schizophrenia, active substance use disorder)
  • Seizure history
  • Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year
  • Pregnancy

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

США · 1 центр
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07399496 · Pro00147039

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗