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Идёт набор NCT07010705

Digital Measures for Clinical Trial Endpoints in Huntington's Disease

— Наблюдательное Huntington Disease Healthy

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: ActiGraph LEAP, Axivity AX6.
Кому может быть актуально
Состояния в реестре: Huntington Disease, Healthy. Базовые параметры: 25 лет — 65 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)

Обзор

MEND-HD is a longitudinal study evaluating the feasibility of passive monitoring of gait and chorea in patients with HD and the meaningfulness of these outcomes for patients with HD and their care partners/support persons. Participants will take part in four virtual visits with study investigators to answer survey questions on movement and cognition, perform in-home movement assessments, and take part in an interview regarding the meaningfulness of gait and chorea in their daily lives. Participant and care partner interviews will be used for symptom mapping and qualitative data analysis to assess the relevance and impact of the targeted symptoms on the participant's daily life. The study may be extended to 3 years to include yearly visits.

Вмешательства

  • Устройство ActiGraph LEAP
    The ActiGraph LEAP has received 510(k) clearance from the US FDA and offers extensive sensor collections, providing continuous digital measures of activity, sleep, mobility, and additional vital signs, including heart rate and variability, oxygen saturation, and skin temperature, in a single fit-for-purpose device.
  • Устройство Axivity AX6
    The Axivity AX6 is a data logger capable of recording raw data from a suite of integrated sensors. It features a state of the art 6-Axis movement sensor measuring linear acceleration and angular velocity at high precision. All sensor locations and Orientations are identical to the AX3 for maximum compatibility. All data is stored in its raw, unaltered format on the embedded flash memory.

Первичные конечные точки

  • Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) [Срок оценки: 1 week]
  • Known Group Validity of Total Time in Chorea (Trunk-Worn Device) [Срок оценки: 1 week]
  • Known Group Validity of Total Time in Chorea (Wrist-Worn Device) [Срок оценки: 2 weeks]
  • Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device) [Срок оценки: 1 week]
  • Known Group Validity of Stride Time Variability (Trunk-Worn Device) [Срок оценки: 1 week]
  • Known Group Validity of Stride Time Variability (Wrist-Worn Device) [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

Inclusion Criteria for participants with adult-onset HD:

  • Age of 25-65 years.
  • Genetically confirmed HD with CAG >= 40 (HD-ISS Stage 2 or mild/moderate Stage 3)
  • English speaking.

Inclusion Criteria for control participants:

  • Age of 25-65 years.
  • English speaking.

Inclusion Criteria for support persons:

  • Self-identified support person or family member of the enrolled participants with HD.
  • 18 years or older
  • English speaking.

Критерии исключения

  • Diagnosis of juvenile-onset HD.
  • History of co-morbid neurological disease or disorders such as stroke, multiple sclerosis, or moderate to severe
  • Traumatic Brain Injury.
  • Use of an assistive device for ambulation.
  • Montreal Cognitive Assessment (MoCA) score of 18 or lower
  • Acute or chronic medical conditions that significantly impact gait or mobility in the opinion of the investigator, e.g. ankle sprain or fracture, or any orthopedic,
  • cardiovascular or psychiatric disease.
  • Pregnancy
  • Cannot be enrolled into a blinded intervention trial at Baseline

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • University of Rochester Medical Center — Rochester

Идентификаторы

NCT: NCT07010705 · STUDY00010159 · 1U01FD008429-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗