NCT07396922

Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments

A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Motion Informatics LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a clinical investigation of the Spatial StimeMD (SSMD) medical device in participants diagnosed with multiple sclerosis (MS). The purpose of the study is to evaluate the safety and performance of the device in a controlled clinical setting. Participants will be followed according to the study schedule and will undergo assessments of MS symptoms, physical function, and other relevant clinical outcomes. Safety will be assessed through monitoring of adverse events and other safety parameters throughout the study. Study data will be collected and reviewed according to the protocol, including verification against source documentation as required.

Conditions

• Stroke
• TBI
• Spinal Cord Injury
• Peripheral Nerve Damage

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-12-30
• Primary completion: 2026-12-30
• Completion: 2027-01-30
• First posted: 2026-02-09
• Last updated: 2026-02-11

Locations

1 site across 1 country: Poland