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Идёт набор NCT07351032

Understanding How Movements Are Transferred From Task to Task in Parkinson's Disease

Без фазы С лечением PARKINSON DISEASE (Disorder)

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: Transcranial Magnetic Stimulation Active, Transcranial Magnetic Stimulation Sham.
Кому может быть актуально
Состояния в реестре: PARKINSON DISEASE (Disorder). Базовые параметры: от 50 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Neural Mechanism of Skill Transfer in Parkinson's Disease

Обзор

The purpose of this study is to understand how a specific brain area, the Posterior Parietal Cortex (PPC), plays a role in movement transfer from walking on a split-belt treadmill (SBT) to walking on the ground in people with Parkinson's disease (PwPD). Here, investigators will apply repeated transcranial magnetic stimulation (rTMS) to upregulate the PPC. Then, the differences in the gait parameters between pre- and post-interventions will be compared between the TMS-active and the TMS-sham.

Подробное описание

The split-belt training has been shown to modulate gait in PwPD, but the skill transfer from the SBT training to the overground walking is poorly understood.

In this project, the subjects will visit the lab on three occasions: day 1 is for the clinical assessment based on the questionnaires, the 10-Meter Walk Task, as well as finding TMS targets and thresholds for the tibialis anterior (TA) and first dorsal interosseous (FDI) muscles, day 2 and day 3 are for either rTMS-active or rTMS-sham intervention. The second and third visits will take place at least 48h a part to ensure that the rTMS effects are washed out between visits.

During these two visits, the participants will first perform pre-overground walking tests (3 minutes): straight walking, steering, and turning, followed by pre-SBT adaptation tests (4 minutes) where they will adapt their gait to the asymmetrical belt that changes every 30 seconds. After these walking tests, the threshold measured on the first day will be validated, and the cortical excitability of the PPC will be measured by using a dual-coil: one is over the TA hotspot, and the other is over the PPC. Then, rTMS or sham intervention will be performed, followed by measuring the cortical excitability of the PPC. Immediately after that intervention, the participants will train on the SBT for 30 minutes in total (with a one-minute break every 5 minutes) with the speed of the belt changing every 30 seconds. Following the SBT training, the participants will perform post-overground and post-SBT adaptation tests. Lastly, the cortical excitability of the PPC will be measured.

Вмешательства

  • Другое Transcranial Magnetic Stimulation Active
    ACTIVE: intermittent Theta Burst Stimulation (a patterned form of rTMS). The participants will receive iTBS (50hz bursts at 5Hz for 600 pulses for a total duration of 3-minutes) over the right PPC at 80% RMT of the FDI.
  • Другое Transcranial Magnetic Stimulation Sham
    SHAM: 2 coils on top of each other will be used instead of 1. The coil furthest to the head will be reversed. The coil on the head will not be stimulating but the reversed coil will (current directed away from the brain) with stimulate with the same parameters at the active stimulation (intermittent Theta Burst Stimulation (a patterned form of rTMS). The participants will receive iTBS (50hz bursts at 5Hz for 600 pulses for a total duration of 3-minutes) over the right PPC at 80% RMT of the FDI.

Первичные конечные точки

  • Stride length [Срок оценки: Day 2 and Day 3]
  • Dual Support [Срок оценки: Day 2 and Day 3]
Вторичные конечные точки (6)
  • Cadence [Срок оценки: Day 2 and Day 3]
  • Gait Speed [Срок оценки: Day 2 and Day 3]
  • Turning Velocity [Срок оценки: Day 2 and Day 3]
  • Steps in turn [Срок оценки: Day 2 and Day 3]
  • Step length [Срок оценки: Day 2 and Day 3]
  • Cortical Excitability [Срок оценки: Day 2 and Day 3]

Критерии участия

Критерии включения

  • a confirmed diagnosis of idiopathic Parkinson's disease
  • absence of freezing of gait confirmed by a "No" answer to the second item of the New Freezing of Gait Questionnaire (NFOGQ) and no observation of FOG during a freezing provoking test
  • no other neurological diagnosis
  • no severe musculoskeletal/orthopedic or vestibular condition that interferes with walking and or significantly affects balance
  • no mild cognitive impairment (Montreal Cognitive Assessment ≥ 25)
  • able to walk independently and without assistive device for 30 minutes
  • no previous experience with split-belt treadmill.

Критерии исключения

  • severe dyskinesia that interacts with walking and balance hearing or visual impairment
  • observed inability to walk safely on a tied-belt treadmill
  • neurological disorders other than PD or other pathology (e.g., orthopedic) interfering with mobility. - contradiction for TMS
  • implanted deep brain stimulator.

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
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • McGill University - Currie Gymnasium — Montreal

Идентификаторы

NCT: NCT07351032 · 24-12-053

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗