Magnetoencephalography (MEG) Pilot Study

Официальное название

Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study

Обзор

The purpose of this research is to learn more about how the brain works in people with essential tremor, and how it changes after treatment with High-Intensity Focused Ultrasound (HiFU). Essential tremor is a movement disorder that causes shaking, usually in the hands, and can make everyday tasks difficult. HiFU is a treatment that uses focused sound waves to target a small area in the brain involved in tremor. In this study, the investigators aim to understand how this treatment affects the brain's networks by using safe, non-invasive tests such as brain imaging, brain wave recordings, and movement assessments.

Подробное описание

Participation in this study will last for approximately eight months. Participants will be asked to attend a total of six study visits. These include a screening visit to see if a potential participant qualifies for the study, an assessment visit before treatment and treatment visits. Prior to and after treatment (one day, six weeks, and six months after treatment), participants will have Magnetoencephalography (MEG), Functional Magnetic Resonance Imaging (fMRI), Sensor-Based Gait and Motor Function Assessments and Self-Report Questionnaires.

Вмешательства

• Диагностический тест MRI and fMRI scans
  functional MRI, diffusion tensor imaging, anatomical MRI
• Диагностический тест MEG
  non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.
• Диагностический тест Sensor-based motor assessments
  research-grade wearable sensors equipped with gyroscopes and accelerometers to precisely and accurately quantify patients' tremors. These sensors will be worn on the wrist or finger, capturing data as patients perform standardized tremor assessment tasks, such as spiral drawing task, writing task, commonly used in essential tremor evaluation. Gait and balance assessments will be conducted by synchronizing multiple sensors placed on the upper and lower extremities as well as the midline. Gait an
• Другое Clinical evaluations
  vital signs, health status review, and neurological exam.
• Другое Questionnaires and rating scales that
  daily functioning, mood, memory, and tremor

Первичные конечные точки

• Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound [Срок оценки: baseline to 7 months]

Вторичные конечные точки (12)

• Correlation between change in tremor amplitude and change in MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between change in tremor frequency and change in MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between change in gait parameters and change in MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between change in postural sway and change in MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between change in 360-degree turn performance and change in MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Change from Baseline in MEG-derived Functional Connectivity Strength [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Change from Baseline in MEG-derived Directed Connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Change from Baseline in MEG-derived Oscillatory Band Power [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Change from Baseline in MEG-derived Network Coherence [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between sonication energy and MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Baseline (pre-treatment) to 6 months post-treatment [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]
• Correlation between number of sonications and MEG connectivity [Срок оценки: Baseline (pre-treatment) to 6 months post-treatment]

Критерии участия

Inclusion:

• Age >50 years and <85 years
• Refractory to at least 2 first line tremor medications
• Skull Density Ratio (SDR) > = 0.35

Exclusion:

• MR/MEG incompatible implants and implantable devices (ex: pacemaker)
• Head tremor interfering with MEG recording
• Severe depression and/or anxiety
• Severe cognitive impairment

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

• UF Health — Gainesville

Идентификаторы

NCT: NCT07446192 · IRB202500103 · OCR48773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗