DBS and Respiration
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: DBS.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease. Базовые параметры: от 18 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
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
Обзор
Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease. The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.
Подробное описание
A continuous cohort of Parkinson disease patients planned to undergo STN-DBS will be approached to participate in this study (i.e. every patient will be offered participation in the study). Over the same time period other DBS patients (GPi and VIM) will be approached before their implantation procedure to participate as controls/comparators. Participants will all be offered the full study, but will also be free to participate in a smaller number of activities if so chosen.
Patients will be assessed both pre-operatively and post-operatively where they will complete a compound respiratory questionnaire and tests of respiratory interoception and function. Post-operatively, these tests will be carried out with stimulation ON and OFF, the order of which will be randomised between patients.
Data on daily activity will be collected during pre- and post-operative windows, using a wearable pedometer/heart-rate monitor.
Positive findings of respiratory neuromodulation will be correlated between patients with structural connectivity (e.g. STN-insula.) from pre-operative MRI scans.
Вмешательства
- Устройство DBS
Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF. DBS implantation itself is part of routine care, and not part of the study.
Первичные конечные точки
- Change in breathlessness [Срок оценки: Pre-operatively and post-operatively (6-months)]
- Change in breathlessness [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
Вторичные конечные точки (9)
- Change in pulmonary function [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in airways resistance [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in respiratory muscle strength [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in surface electromyography of respiratory muscles [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in hypercapnic ventilatory response [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in breath-hold [Срок оценки: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in daily activity [Срок оценки: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)]
- Change in daily activity [Срок оценки: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)]
- MRI structural connectivity [Срок оценки: Pre-operative scan with post-operative analysis through study completion at an average of 1 year]
Критерии участия
Критерии включения
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Planned for required DBS surgery
- Fluent in the English language
- For experimental group: diagnosed with Parkinson's disease
Критерии исключения
- Female who is pregnant
- Subject is currently participating in a clinical investigation that includes an active treatment arm which may affect the respiratory system.
- Acute respiratory problem at time of experimental session: e.g. rhinosinusitis, pharyngitis, asthma exacerbation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Великобритания · 1 центр
- John Radcliffe Hospital — Oxford
Идентификаторы
NCT: NCT04058457 · 256825