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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06672458
Status
Recruiting
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Conditions

  • Peripheral Nerve Injuries
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MyndMove Short Term Therapy — DEVICE
    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.
  • Conventional Short Term Therapy — OTHER
    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
  • MyndMove Long Term Therapy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Acute SCI Group
    Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; less than 6 months post injury. Participants in this group will be in the study for up to 12 weeks
  • Experimental: Chronic SCI Group
    Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; more than 6 months post injury. Participants in this group will be in the study for up to 12 weeks
  • Experimental: Acute PNI Group
    Individuals with PNI that are within 6 months pre- or post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks
  • Experimental: Chronic PNI Group
    Individuals with PNI that are 6 months or more post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks

Primary Outcome Measure

Nine Hole Peg Test [ Time Frame: baseline and up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami - Miami Project to Cure ParalysisMiamiFlorida33136
Matija Milosevic, PhD
[email protected]
(305) 243-3572
Deena Cilien, DPT
[email protected]
(305) 243-9301
Matija Milosevic, PhD (PRINCIPAL_INVESTIGATOR)

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University of Miami - Miami Project to Cure Paralysis· Miami, FL

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