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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade

Group 1 (Acute SCI): Deemed medically stable by medical practitioner, less than 6 months post-injury.

Group 2 (Chronic SCI): More than 6 months post-injury.

Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery

Disqualifiers

Traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.

Severe spasticity that could prevent the study protocol as determined by the investigator.

Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.

Has contraindications for transcutaneous stimulation using FES such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Acute SCI GroupExperimental treatment 3 interventions
Group B: Chronic SCI GroupExperimental treatment 3 interventions
Group C: Acute PNI GroupExperimental treatment 3 interventions
Group D: Chronic PNI GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Nine Hole Peg Test

The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Test is performed at the beginning and end of each intervention visit. Scores are based on the time taken to complete the activity, recorded in seconds. (Only for subjects in short term intervention)

Time frame
baseline and up to 2 weeks
2

Surface EMG

EMG signals (measured in volts) recorded by skin surface EMG electrodes placed on the arm(s) during muscle contraction to evaluate muscle activity and motor unit activity at the beginning and end of each intervention visit. (Only for subjects in short term intervention)

Time frame
baseline and up to 2 weeks
3

Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)

GRASSP test will be used to assess upper arm motor function. Series of tasks will test subject's strength, sensation, and prehension. The prehension ability sub-test is scored for a total max score of 30 for each arm, using a scale from 0-30 where 0 is no upper arm motor function and 30 is full upper arm motor function. (Only for subjects in long term intervention)

Time frame
baseline, 12 weeks
4

Manual Muscle Test (MMT) with FES

A test that measures muscle strength and function with FES via MyndMove. Each muscle group tested (varies) will be scored from 0-5, where 0 is indicating no movement and strength and a max score of 5 indicating full, normal movement and strength. (Only for subjects in long term intervention)

Time frame
baseline, 12 weeks

Secondary outcomes

Other outcomes

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