What is the mechanism of action of this treatment?

Common treatments for Spinal Cord Injury (SCI) include physical therapy, occupational therapy, and assistive technologies like the MyHand-SCI device. Physical and occupational therapies aim to improve motor function and independence through targeted exercises and activities. Assistive technologies, such as active hand orthoses, work by providing mechanical support and enhancing the user's ability to perform daily tasks. These treatments are crucial for SCI patients as they help restore some degree of function, improve quality of life, and promote greater independence.

What side effects are associated with this type of intervention?

Common treatments for spinal cord injury (SCI) that focus on hand function, such as electrical stimulation devices and assistive orthoses, generally have mild side effects. These can include skin irritation, muscle fatigue, and discomfort at the site of application. In some cases, users may experience temporary numbness or tingling. More broadly, treatments for SCI can also involve physical therapy and medications, which may lead to side effects like muscle soreness, sedation, or gastrointestinal issues. It is important to consult with a healthcare provider to tailor the treatment plan to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Spinal Cord Injury (SCI), focusing primarily on pharmacological interventions, surgical procedures, and rehabilitation therapies. However, specific FDA-approved assistive technologies for hand function in SCI, similar to the MyHand-SCI device, are less commonly highlighted. Broadly, treatments for SCI include devices like functional electrical stimulation (FES) systems, which help improve motor function, and exoskeletons designed to aid mobility. These technologies aim to enhance the quality of life for individuals with SCI by improving their ability to perform daily activities.

What other types of research exist?

Promising novel alternatives to the MyHand-SCI device for spinal cord injury patients in 2024 include: 1) Neuroprosthetics that utilize brain-computer interfaces (BCIs) to control hand movements, 2) Advanced exoskeleton gloves that provide enhanced dexterity and strength, 3) Soft robotic gloves that offer improved comfort and adaptability, and 4) Functional electrical stimulation (FES) systems that stimulate muscle contractions to restore hand function. These technologies are being refined through ongoing research and clinical trials, showing potential for significant improvements in hand function for SCI patients.

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Active Hand Orthosis

Hand Orthosis for Spinal Cord Injury

N/A

Recruiting

Led By Joel Stein, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function

Be older than 18 years old

Must not have

Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device

Severe spasticity (modified Ashworth >2) at elbow, wrist, or fingers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years at study completion

Awards & highlights

Summary

This trial is testing the MyHand-SCI device, which helps people with C6-C7 spinal cord injuries use their hands better. The device combines physical support and smart technology to improve hand movements.

Who is the study for?

This trial is for individuals with C6-C7 spinal cord injury who are at least 6 months post-injury and have significantly reduced hand and finger function. They must be able to consent to the study. People with open wounds, severe upper limb pain, intense spasticity, or fixed contractures that limit arm use cannot participate.

What is being tested?

The MyHand-SCI trial is testing a device designed to help people with specific spinal cord injuries regain hand functions. Participants will use the MyHand-SCI orthosis, which aims to improve their ability to perform daily tasks by enhancing motor control and strength in their hands.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device, skin irritation where it contacts the body, muscle fatigue due to new movements or extended usage of the device, and possible exacerbation of existing spasticity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My hand and finger control is greatly reduced due to my spinal cord injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use my hand or arm well because they are stiff and cannot move.

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I have severe muscle stiffness in my arm or hand.

Select...

I have open wounds or my skin tears easily.

Select...

I have constant severe pain in my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years at study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years at study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years at study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

System Usability Scale

Trial Design

1Treatment groups

Experimental Treatment

Group I: MyHand-SCI Device TestingExperimental Treatment1 Intervention

Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) include physical therapy, occupational therapy, and assistive technologies like the MyHand-SCI device. Physical and occupational therapies aim to improve motor function and independence through targeted exercises and activities. Assistive technologies, such as active hand orthoses, work by providing mechanical support and enhancing the user's ability to perform daily tasks. These treatments are crucial for SCI patients as they help restore some degree of function, improve quality of life, and promote greater independence.

Upper Extremity Assessment in Tetraplegia: The Importance of Differentiating Between Upper and Lower Motor Neuron Paralysis.