Actively Recruiting
Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
Led by University of Miami · Updated on 2026-04-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of functional electrical stimulation (FES) therapy on the function of the arms, brain, and spinal cord in people with spinal cord injury (SCI) or peripheral nerve injury (PNI). The study aims to understand recovery patterns using the MyndMove therapy system, which uses electrical stimulation to help people perform daily tasks, exercise, and strengthen muscles. This research focuses on individuals with traumatic SCI at or above the T1 spinal level and those with PNI, evaluating different stages of injury and nerve transfer surgery recovery. Participants will receive either MyndMove FES therapy or conventional therapy. MyndMove Short Term Therapy consists of one in-person session within two weeks using surface electrical stimulation to activate muscles and perform arm and hand tasks. MyndMove Long Term Therapy involves up to 40 one-hour sessions delivered three to five times weekly over 12 weeks, focusing on regaining voluntary arm movements. Conventional therapy includes similar hand and arm functional tasks without electrical stimulation. Four groups participate based on injury type and time since injury or surgery, each involved in the study for up to 12 weeks. During the study, participants will undergo assessments such as the Nine Hole Peg Test, surface EMG, the GRASSP Prehension Performance, and Manual Muscle Test with FES at baseline, during, and after the therapy period. The study involves monitoring muscle and motor function recovery using these tests to measure changes in arm and hand abilities. Participants commit to intervention and assessment sessions over a maximum of four months, with safety and functional progress closely evaluated throughout the study.
CONDITIONS
Brief Title
Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Traumatic spinal cord injury at or above T1 spinal level with AIS A, B, C, or D impairment grade
- Less than 6 months post-injury and medically stable (Acute SCI group) or more than 6 months post-injury (Chronic SCI group)
- Peripheral nerve injury pre- or post-upper extremity nerve transfer surgery, medically stable and safe to participate
- Detectable residual muscle connection in at least one upper limb confirmed by visible contraction with FES
- Detectable motor function in at least one upper extremity muscle confirmed by voluntary electromyography or motor evoked potential
- Able to commit to intervention and assessment sessions over up to 4 months (Aim 2 only)
You will not qualify if you...
- History of traumatic brain injury, stroke, multiple sclerosis, or other neuromotor disorders
- Severe spasticity preventing study protocol
- Major executive dysfunction, dementia, depression, neurocognitive impairments, or serious medical conditions
- Contraindications for FES such as skin breakdown, thrombosis, or skin disease in electrode area
- Poorly managed autonomic dysreflexia triggered by FES
- Unhealed upper extremity fractures, contractures, or pressure sores
- Implanted neurostimulators like deep brain stimulation or vagal nerve stimulators
- Cardiac pacemaker or intracardiac lines
- Need for other therapies or care interfering with study participation
- Use of investigational drugs or other interventions affecting neuromotor function
- Substance abuse disorders including alcoholism and drug abuse
- Pregnancy, breastfeeding, or desire to become pregnant during the study
- Any condition making participation unsafe or inappropriate as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive either MyndMove Functional Electrical Stimulation (FES) therapy or Conventional therapy during in-person sessions to improve upper extremity function.
1 visit (one hour duration) delivered within a 2 week period, in person
Duration - Up to 12 weeks
Participants undergo MyndMove Long Term FES upper arm therapy with one-hour in-person sessions up to 40 sessions over a period of up to 12 weeks to regain voluntary arm movements.
Up to 40 sessions delivered no less than 3 and up to 5 times per week (in-person)
Trial Site Locations
Total: 1 location
1
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
C
Cristina Thurston, DPT
D
Deena Cilien, DPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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