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Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Sponsor: Motion Informatics LTD
Summary
This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.
Official title: A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-12-30
Completion Date
2027-01-30
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
SSMD
SSMD device-based therapy delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Functional Electrical Stimulation (FES)
Functional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Locations (1)
Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń
Ustroń, Poland