MSPT Device Usability Study
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | March 2016 |
| Contact: | Biogen |
| Email: | clinicaltrials@biogen.com |
The Multiple Sclerosis Performance Test (MSPT) Device for Functional Assessment of Multiple Sclerosis (MS) Patients
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.
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.
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.
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.
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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.
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