MSPT Device Usability Study

Biogen

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02664324

888MS003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.