Spinal Cord InjuriesNCT06672458
Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
A study testing MyndMove Short Term Therapy, Conventional Short Term Therapy and MyndMove Long Term Therapy in people with Spinal Cord Injuries and Peripheral Nerve Injuries, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Peripheral Nerve Injuries
- What is being tested?
- MyndMove Short Term Therapy, Conventional Short Term Therapy and MyndMove Long Term Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Neurological Injury:
- 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
- Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery
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- 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.
Who cannot join
- 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
- Poorly managed autonomic dysreflexia that could be triggered by FES.
- Unhealed upper extremity fracture, contracture, or pressure sore.
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- Implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation (VNS))
- Cardiac pacemaker or intracardiac lines.
- Individuals who require therapy or other care that could interfere with participation in the study.
- Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
- Individuals with substance disorders, including alcoholism and drug abuse.
- Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
- In the opinion of the investigators, the study is not safe or appropriate for the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136
Matija Milosevic, PhD, (305) 243-3572, mmilosevic@med.miami.edu
Deena Cilien, DPT, (305) 243-9301, dcilien@med.miami.edu
About this study
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
- Being tested
- MyndMove Short Term Therapy, Conventional Short Term Therapy, MyndMove Long Term Therapy
- Medical subject headings
- Spinal Cord Injuries, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyndMove Short Term TherapyDevice
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 TherapyOther
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 TherapyDevice
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 group | Role | What they receive |
|---|---|---|
| Acute SCI Group | Experimental | 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 Receives: Device: MyndMove Short Term Therapy; Other: Conventional Short Term Therapy; Device: MyndMove Long Term Therapy |
| Chronic SCI Group | Experimental | 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 Receives: Device: MyndMove Short Term Therapy; Other: Conventional Short Term Therapy; Device: MyndMove Long Term Therapy |
| Acute PNI Group | Experimental | 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 Receives: Device: MyndMove Short Term Therapy; Other: Conventional Short Term Therapy; Device: MyndMove Long Term Therapy |
| Chronic PNI Group | Experimental | 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 Receives: Device: MyndMove Short Term Therapy; Other: Conventional Short Term Therapy; Device: MyndMove Long Term Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and up to 2 weeks
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)
Measured: baseline and up to 2 weeks
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)
Measured: baseline, 12 weeks
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)
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matija Milosevic, University of Miami
- Investigators
- Matija Milosevic, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672458
- Sponsor's protocol ID
- 20240966
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT06672458
- Acronym / sponsor ID
- 20240966
- Conditions
- Spinal Cord Injuries, Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute SCI Group | Experimental | Device: MyndMove Short Term Therapy, Other: Conventional Short Term Therapy, Device: MyndMove Long Term TherapyIndividuals 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 |
| Chronic SCI Group | Experimental | Device: MyndMove Short Term Therapy, Other: Conventional Short Term Therapy, Device: MyndMove Long Term TherapyIndividuals 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 |
| Acute PNI Group | Experimental | Device: MyndMove Short Term Therapy, Other: Conventional Short Term Therapy, Device: MyndMove Long Term TherapyIndividuals 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 |
| Chronic PNI Group | Experimental | Device: MyndMove Short Term Therapy, Other: Conventional Short Term Therapy, Device: MyndMove Long Term TherapyIndividuals 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade
- or
- Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (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.
Key exclusion criteria (13 listed)
- 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
- Poorly managed autonomic dysreflexia that could be triggered by FES.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyndMove Short Term TherapyFES 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. | Device | Acute PNI Group, Acute SCI Group, Chronic PNI Group, Chronic SCI Group |
| Conventional Short Term TherapyTherapy 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 | Other | Acute PNI Group, Acute SCI Group, Chronic PNI Group, Chronic SCI Group |
| MyndMove Long Term TherapyFES 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. | Device | Acute PNI Group, Acute SCI Group, Chronic PNI Group, Chronic SCI Group |
Primary outcome
Nine Hole Peg Test
Time frame: baseline and up to 2 weeks
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)
Surface EMG
Time frame: baseline and up to 2 weeks
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)
Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)
Time frame: baseline, 12 weeks
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)
Manual Muscle Test (MMT) with FES
Time frame: baseline, 12 weeks
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matija Milosevic, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyndMove Short Term Therapy, Conventional Short Term Therapy and MyndMove Long Term Therapy in people with Spinal Cord Injuries and Peripheral Nerve Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Thurston, DPT ((305) 243-9301, cst58@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (time frame: baseline and up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.