The Multiple Sclerosis Performance Test (MSPT) Device for Functional Assessment of Multiple Sclerosis (MS) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent (%) of study participants successfully completing all modules of the MSPT device
研究概览
简要总结
The primary objective of this feasibility study is to evaluate the functionality (e.g., as defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance Test (MSPT) device, when used by unsupervised participants with MS, or related conditions, with a broad range of disability, in multi-clinical-care environments. Secondary objectives include: Participant perception of usability of device; Participant satisfaction with the device; Ascertain the impact of different clinical environments on device usability; Ascertain impact of assistive devices in usability of device; Ascertain functionality of Bluetooth remote as compared with manual timing.
详细描述
This study does not involve evaluation(s) of the clinical efficacy of the MSPT device or the efficacy of MS therapies. This feasibility study is examining the usability of the fully integrated MSPT device. Study participants will be enrolled for same-day testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS, or related conditions, such as: Clinically Isolated Syndrome (CIS), Neuromyelitis Optica (NMO), and Transverse Myelitis (TM)
- •Literacy of written English language as displayed on software tool
- •Ability to understand and comprehend software tool from the audio and visual instructions provided in English
排除标准
- •Study participants, who in the opinion of the Investigator, have vision impairment that precludes their ability to see the iPad Air2® screen/MSPT device.
- •Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (>30 minutes), cerebral palsy, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, Parkinson's disease, and Huntington's disease.
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
结局指标
主要结局
Percent (%) of study participants successfully completing all modules of the MSPT device
时间窗: Through study duration (3-4 hours)
Number of study participants successfully completing all modules of the MSPT device
时间窗: Through study duration (3-4 hours)
The MSPT software tool builds upon previously validated measures comprising the Multiple Sclerosis Functional Composite (MSFC) that represents a comprehensive functional assessment of MS participants that include: MyHealth: MS -Patient demographic, health and medication information; NeuroQoL - Neurological Quality of Life test -Participant reported; PST Processing Speed Test- Measures mental processing speed; Contrast Sensitivity Test (CST)- 50cm vision test; MDT Manual Dexterity Test- 9 hole peg test; WST Walking Speed Test - Timed 25 foot walk
次要结局
- Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device(Through study duration (3-4 hours))
- Between-site differences in percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6 to 9) on appropriate questions on the MSPT Usability Survey(Through study duration (3-4 hours))
- The percent (%) of study participants who have usability issues with Bluetooth remote due to use of an assistive device(s)(Through study duration (3-4 hours))
- Between-site differences in percent (%) of study participants who select satisfied/completely satisfied on MSPT Satisfaction Survey(Through study duration (3-4 hours))
- Difference of manual timed versus Bluetooth timed in Walking Speed Test (WST) as assessed by Timed 25 foot walk(Through study duration (3-4 hours))
- Percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6-9) on appropriate questions on the MSPT Usability Survey(Through study duration (3-4 hours))