NCT06672458

Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.

Conditions

• Spinal Cord Injuries
• Peripheral Nerve Injuries

Interventions

Type	Name	Description
DEVICE	MyndMove Short Term Therapy	FES therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. FES therapy uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements the single use electrodes will be placed in various combinations on the surface of the different upper arm muscles. Participants will perform hand and finger dexterity tests as well as arm functional mobility tasks while receiving FES.
OTHER	Conventional Short Term Therapy	Therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. Conventional therapy will consist of performance hand and finger dexterity tests as well as arm functional mobility tasks
DEVICE	MyndMove Long Term Therapy	FES upper arm therapy will be provided in one-hour in-person sessions for a maximum of 40 sessions delivered no less than 3 times per week and up to 5 times per week during a period of up to 12 weeks. Over the course of 40 sessions, participants will progress through various movement sequences aimed at regaining natural, unassisted voluntary movements in the affected arms while receiving FES.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2024-11-04
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study