Digital Measures for Clinical Trial Endpoints in Huntington's Disease (MEND-HD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
20 HD-ISS mild or moderate Stage 3
(CAG ≥40 and sign symptom and functional impact) with or without a support person or family member
干预措施: ActiGraph LEAP (Device)
20 Healthy controls
age and sex-matched
干预措施: Axivity AX6 (Device)
20 HD-ISS Stage 2
(CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member
干预措施: Axivity AX6 (Device)
20 HD-ISS Stage 2
(CAG ≥ 40 and sign/symptom of HD) with or without a support person or family member
干预措施: ActiGraph LEAP (Device)
20 HD-ISS mild or moderate Stage 3
(CAG ≥40 and sign symptom and functional impact) with or without a support person or family member
干预措施: Axivity AX6 (Device)
20 Healthy controls
age and sex-matched
干预措施: ActiGraph LEAP (Device)
结局指标
主要结局
Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device)
时间窗: 1 week
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Known Group Validity of Total Time in Chorea (Trunk-Worn Device)
时间窗: 1 week
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Known Group Validity of Total Time in Chorea (Wrist-Worn Device)
时间窗: 2 weeks
Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device)
时间窗: 1 week
Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the agreement between trunk-worn and wrist-worn devices among HD and control participants.
Known Group Validity of Stride Time Variability (Trunk-Worn Device)
时间窗: 1 week
Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the trunk-worn device to differentiate between HD and control participants.
Known Group Validity of Stride Time Variability (Wrist-Worn Device)
时间窗: 2 weeks
Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants.
次要结局
未报告次要终点
研究者
Jamie Adams
Associate Professor - Department of Neurology
University of Rochester