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

Sponsor
Motion Informatics LTD
Study ID
NCT07396922
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SSMD — DEVICE
    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) — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Dec 30, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SSMD + Conventional Therapy
    Participants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks.
  • Active Comparator: FES + Conventional Therapy
    Participants receive functional electrical stimulation (FES) sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks.

Primary Outcome Measure

Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score [ Time Frame: Baseline to post-treatment (end of treatment, 3 weeks) ]

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