Trials Today

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

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Neurological Injury: 1. 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. or 2. Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery - Group 3 (Acute Pre- or Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon within 6 months pre- or post-UE nerve transfer surgery. - Group 4 (Chronic Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon 6 months or more post-UE nerve transfer surgery. 3. Has detectable residual connection in upper-limb muscles in at least one of the neurologically affected sides confirmed by a visible contraction when functional electrical stimulation (FES) is applied in at least one upper extremity muscle at baseline. 4. Has detectable motor function in at least 1 upper extremity muscle on 1 neurologically affected side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) at the baseline assessment. 5. (Aim 2 only) Able to commit to intervention and assessment sessions over a maximum duration of 4 months.

Exclusion Criteria

Traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function. 2. Severe spasticity that could prevent the study protocol as determined by the investigator. 3. Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities. 4. 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 5. Poorly managed autonomic dysreflexia that could be triggered by FES. 6. Unhealed upper extremity fracture, contracture, or pressure sore. 7. Implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation (VNS)) 8. Cardiac pacemaker or intracardiac lines. 9. Individuals who require therapy or other care that could interfere with participation in the study. 10. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function. 11. Individuals with substance disorders, including alcoholism and drug abuse. 12. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study. 13. In the opinion of the investigators, the study is not safe or appropriate for the participant.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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	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.
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	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.
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	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.
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	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.

Recruiting Locations

University of Miami - Miami Project to Cure Paralysis
Miami, Florida 33136

Contact:
Matija Milosevic, PhD
305-243-3572
mmilosevic@med.miami.edu

More Details

NCT ID: NCT06672458
Status: Recruiting
Sponsor: University of Miami

Study Contact

Cristina Thurston, DPT
(305) 243-9301
cst58@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.