Spinal Cord Injuries study: MyndMove Short Term Therapy vs MyndMove Long Term Therapy
Official title Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
ClinicalTrials.gov ID: NCT06672458
What this study is testing
- What it's testing
- This study is testing whether the MyndMove device can improve arm movement and muscle strength in people with spinal cord or peripheral nerve injuries.
- Who it's for
- You may be able to join if you have a spinal cord injury or a peripheral nerve injury and can use a small device at home.
- What's involved
- You will use the MyndMove device at home, following a set schedule of sessions. The study team will check your progress with simple tests and questionnaires.
- Time commitment
- The study lasts several weeks, with regular home sessions and occasional clinic visits for assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
- Group 3 (Acute Pre- or Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy...
You likely can't join if
- 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...
- Poorly managed autonomic dysreflexia that could be triggered by FES.
- Unhealed upper extremity fracture, contracture, or pressure sore.
See the full eligibility criteria
- 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
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.